FCC ID: 2A7FYIS3800W IS 3800W

Notice The Safety, Regulatory and Technical Specifications User Guide includes information on the safety instructions, regulatory information, and the technical specifications of the devices. We recommend that you thoroughly familiarize yourself with this guide to make the most effective use of your system. Dental Imaging Technologies Corporation, 2022-2023. The information in this document is subject to change. Neither Dental Imaging Technologies Corporation nor any of its subsidiaries shall be liable for errors contained herein or for incidental damages in conjunction with the furnishing, performance, or use of this material. No part of this publication may be reproduced without the permission of Dental Imaging Technologies Corporation. The IS 3800 Family comprises:

IS 3800W IS 3800 This document is originally written in English. All trademarks and registered trademarks are the property of their respective holders. The IS 3800W and IS 3800 are intended for professional use only. U.S. Federal law restricts this device to sale by or on the order of a dentist. If any serious incident occurs in relation to the device, the user must report it to Dental Imaging Technologies Corporation and to the competent authority of its Member State in the European Union. IS 3800 Family Safety, Regulatory, and Technical Specifications Manual Name:

User Guide Part Number: TA3977M1 Revision: E Print Date: 2023-12 The IS 3800W and IS 3800 comply with Medical Device Regulation (EU) 2017/745 and Medical Devices Regulations 2002 (SI618) as subsequently amended by the EU Exit Regulations of 2019 (SI 791) and 2020 (SI 1478). Contents Chapter 1 Safety Information Chapter 2 Regulatory Information Chapter 3 Technical Specifications Indications for Use . . . . . . . 1 Clinical Benefits and Performance Characteristics . . . . . . . . . 1 Conventions in This Guide . . . . 2 Warnings and Safety Instructions. 3 Cleaning, Disinfecting, Sterilizing. 7 Cleaning and Disinfecting the Scanner . . . . . . . . . . . 7 Cleaning the Scanner . . . 9 Disinfecting the Scanner . . 10 Cleaning and Sterilizing the Scan-

ner Tips . . . . . . . . . . . 10 Manually Cleaning the Scanner Tips . . . . . . . . . . . 12 Cleaning the Scanner Tips in an Automatic Washer or Disin-

fector . . . . . . . . . . . 12 Sterilizing the Scanner Tips. 13 Precautions Before Use . . . . . 14 Cleaning, Disinfecting, and Steril-

izing . . . . . . . . . . . . . 14 Visually Inspecting the Scanner14 Visually Inspecting the Scanner Tips . . . . . . . . . . . . . 14 Marking and Labeling Symbols . . 15 Label Locations . . . . . . . . . 16 IS 3800W Labels . . . . . . . 16 IS 3800 Labels . . . . . . . . 20 General Regulatory Information . 23 WiFi . . . . . . . . . . . . . 26 Guidance and Manufacturers Declarations . . . . . . . . . . 27 Compliance with International Regulations . . . . . . . . . . . 31 Factory . . . . . . . . . . . . . 33 Manufacturer . . . . . . . . . . 33 Model . . . . . . . . . . . . . 33 DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977M1)_RevisionE iii IS 3800 Family Technical Specifications. . . . . . . . . . 34 IS 3800W . . . . . . . . . . 34 IS 3800 . . . . . . . . . . . 35 Length of Cables Supplied with the Unit . . . . . . . . . . . . . . 36 IS 3800 Family Environmental Requirements . . . . . . . . . 37 Computer System Requirements. 37 Manufacturers Address . . . . . 39 European Community . . . . . 39 UK Responsible Person. . . . 39 List of Importers for European Union According to the MDR 2017/745 . 39 Chapter 4 Contact Information iv 1 Safety Information Indications for Use The IS 3800 Family system is a digital optical scanning device used to record the topographic characteristics of teeth or dental impressions in three dimensions. The resulting topographic impressions are intended for use in the computer-aided design and manufacturing of dental restorative prosthetic devices, dental implant prosthetic devices, and orthodontic models. Clinical Benefits and Performance Characteristics DEXIS intraoral scanners benefit a dental practice by enabling practitioners to acquire digital impressions with the quality and accuracy required for digital CAD/CAM dental applications. The actual performance of the device is dependent on the user's training and operating execution. The user is solely responsible for the accuracy, completeness, and adequacy of the acquired data. DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977M1)_RevisionE 1 Conventions in This Guide The following special messages emphasize information or indicate potential risks to personnel or equipment. WARNING: Warns you to avoid injury to yourself or others by following the safety instructions precisely. Caution: Alerts you to a condition that might cause serious damage. Important: Alerts you to a condition that might cause problems. Note: Emphasizes important information. Tip: Provides extra information and hints. 2 Chapter 1 Safety Information Warnings and Safety Instructions DANGER OF ELECTRIC SHOCK This is an electrical unit. Do NOT expose it to water spray. Such action can cause an electric shock or a malfunction of the unit. IMPORTANT: All known residual risks, contraindications, or undesirable side effects are listed in this guide. If any serious incident occurs in relation to the device, you must report it to DEXIS and to the competent authority of your Member State in the European Union. WARNINGS IS 3800 Family:

You MUST read and understand this safety information before using the scanner. This scanner shall only be used inside hospitals and other professional healthcare facilities and MUST NOT be used near high frequency surgical equipment and the RF shielded room of an ME System for magnetic resonance imaging, where the intensity of electromagnetic disturbance is high. Before using the scanner, check the outer surfaces of the unit and any accessories to ensure there are no rough surfaces, sharp edges, or protrusions which may cause a safety hazard. You are responsible for the operation and maintenance of the scanner. You MUST have training to use the scanner. DO NOT place objects within the field of operation of the unit. When the unit is not in use, ensure that the scanner is turned OFF. DO NOT use the scanner in conjunction with oxygen-rich environments. This unit is not intended for use with flammable anesthetics or flammable agents. DO NOT pull or twist the cable. DO NOT drop the scanner or the accessories. DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977M1)_RevisionE 3 DO NOT heat sterilize the scanner. DO NOT expose the scanner to water spray or submerge it in water or disinfectant. DO NOT expose the scanner to high vibrations. DO NOT expose the scanner to ultraviolet radiation directly. The scanner is not designed for ultraviolet disinfection. DO NOT stare at the LED emission window. When the tip is removed, install the rubber cover to protect the scanner lens window. DO NOT remove the cover of any scanner components. The scanner contains no user-serviceable parts. For any repairs, contact a qualified DEXIS service technician. DO NOT replace the cables provided with the scanner with other cables. Doing so may damage the scanner and adversely affect the safety protection and EMC performance of the scanner. DO NOT replace the power adapter provided with the scanner with any other power adapter. Substitutes may not provide the required protection against electric shocks and other safety hazards. If the equipment is faulty, turn it OFF, display an Out of Service notice, and contact a qualified DEXIS service technician. Using components, accessories, cables, and spare parts other than those specified or provided by the manufacturer of this equipment may impair the safety protection of the scanner and may result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. No modification of this equipment is allowed. Additional multiple outlet strips or extension cords should not be connected to the system. The maximum temperature of the applied part may reach to 43 C;

to avoid overheating, do not use it for extended periods. To power off the device, push the power button for 3 seconds. To isolate the device from mains supply on all poles, unplug the adapter from the mains power outlet. DO NOT maintain or service this equipment while it is in use with the patient. Always position the unit in such a way that it is easy to disconnect the adapter from the mains power outlet. Connection of the PEMS (Programmable Electrical Medical System) to an IT NETWORK that includes other equipment could 4 Chapter 1 Safety Information result in risks to patients, operators, or third parties. The responsible organization should identify, analyze, evaluate, and control these risks. Computer / Other Equipment:

All devices meeting IEC60950 or IEC62368 must be kept outside the patient environment as defined in IEC60601-1, unless equipped with an additional protective earth or an extra isolating transformer. See the installation guide for your computer for information about the data processing system, computer, and screen. Leave a sufficient amount of clear space around the computer to ensure that it is properly ventilated. Position the screen to avoid light reflections from internal or external lighting for maximum image quality and visual comfort. IS 3800W Battery:

Do not dismantle, open, or shred secondary cells or batteries. Do not expose cells or batteries to heat or fire. Avoid storage in direct sunlight. Do not short-circuit a cell or a battery. Do not store cells or batteries haphazardly in a box or drawer where they may short-circuit each other or be short-circuited by other metal objects. Do not remove a cell or battery from its original packaging until required for use. Do not subject cells or batteries to mechanical shock. In the event of a cell leaking, do not allow the liquid to come in contact with the skin or eyes. If contact has been made, wash the affected area with copious amounts of water and seek medical advice. Do not use any charger other than that specifically provided for use with the equipment. Refer to the manufacturers instructions or equipment manual for proper charging instructions. Do not use any cell or battery which is not designed for use with the equipment. Always purchase the battery recommended by the device manufacturer for the equipment. Keep cells and batteries clean and dry. DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977M1)_RevisionE 5 Wipe the cell or battery terminals with a clean, dry cloth if they become dirty. Do not leave a battery on prolonged charge when not in use. After extended periods of storage, it may be necessary to charge and discharge the cells or batteries several times to obtain maximum performance. Retain the original product literature for future reference. Use only the cell or battery in the application for which it was intended. When possible, remove the battery from the equipment when not in use. Dispose of properly. Disposal:

This equipment contains certain materials and chemical compounds incidental to the manufacture of electrical and electronic equipment, and improper end-of-life disposal of such equipment can result in environmental contamination. Therefore, this equipment should not be disposed of as ordinary household waste but should instead be delivered to a designated electrical and electronic waste disposal or recycling center. For further information on disposing of electrical and electronic waste, contact the cognizant authority within the local jurisdiction. Dispose of the scanner tips according to standard operating procedures or local regulations for the disposal of contaminated medical waste. For additional scanner tips, contact your dealer. 6 Chapter 1 Safety Information Cleaning, Disinfecting, Sterilizing Cleaning and Disinfecting the Scanner WARNINGS Read and follow the warnings and personal protection instructions provided in the Safety Data Sheet (SDS) for the disinfectant used to process the scanner for reuse. You must wear gloves while cleaning and disinfecting the scanner. The scanner must be disinfected with an U.S. Environmental Protection Agency (EPA) registered or CE marked intermediate-level disinfectant solution with tuberculocidal activity between patients. DO NOT use a disinfectant containing phenolics or iodophors; doing so will damage the surface coating of the scanner. Never put the scanner in an autoclave device or immerse it in water or the disinfectant solution. Excessive fluids can damage the scanner. Do not use cotton, cloth, or tissues soaked with disinfectant to disinfect the scanner. IMPORTANT: Do NOT remove the detachable part

(battery or cable) from the scanner when cleaning and disinfecting unless you see it necessary. IMPORTANT: Make sure the contact points on the IS 3800W handpiece, battery and charging station are dry and clean after cleaning and disinfecting, in order to avoid risk of short circuit. Figure 1 Contact points on IS 3800W handpiece DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977M1)_RevisionE 7 Figure 2 Contact points on battery Figure 3 Contact points on IS 3800W handpiece charging station Figure 4 Contact points on IS 3800W battery charging station Caution: DO NOT allow liquid to enter through the gap, air inlet/outlet, or pin holes when cleaning and disinfecting the scanner. Figure 5 Gap between covers 8 Chapter 1 Safety Information Figure 6 Pin holes and air outlet Figure 7 Air inlet - IS 3800W Figure 8 Air Inlet - IS 3800 Cleaning the Scanner If the scanner is visibly contaminated with blood and/or body fluids, you must clean it before disinfecting it. To clean the scanner, follow these steps:

1 2 Dampen (do not soak) a lint-free cloth with lukewarm water. Remove the blood and/or body fluids with the dampened lint-free cloth. DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977M1)_RevisionE 9 Disinfecting the Scanner After each patient, the scanner must be thoroughly disinfected. To adequately disinfect the scanner, follow the disinfectant manufacturers instructions for the appropriate contact time. Important: If the scanner is visibly soiled, it must be thoroughly cleaned prior to disinfecting. See Cleaning the Scanner. To disinfect the scanner, follow these steps:

1 2 3 Remove the reusable tip. Remove all visible soil (see Cleaning the Scanner ). Use a commercially prepared intermediate level disinfectant wipe. Follow the manufacturers instructions for contact time. Approved disinfectant wipes: Mikrozid AF Jumbo Wipes, CaviWipes, Oxivir Tb Wipes, Clorox Healthcare Bleach Germicidal Wipes, PDI Sani-Cloth Bleach Germicidal Wipes. WARNING: Using a disinfectant that has not been approved may cause damage to the scanner. 4 Thoroughly wipe all surfaces of the scanner. WARNING: Do not rinse. 5 6 Allow to air dry. After the scanner has dried, use a clean, lint-free cloth dampened with water to remove residual disinfectant from the surface of the scanner. Cleaning and Sterilizing the Scanner Tips Scanner tips received from the manufacturer are NOT sterile. You must sterilize the tips before the first use. 10 Chapter 1 Safety Information If you limit the exposure time at 134C to not more than 4 minutes, you can autoclave the tip up to 110 cycles. WARNINGS Wear gloves when handling a contaminated scanner tip. Read and follow the warnings and personal protection instructions provided in the manufacturers SDS for the detergent used to clean the scanner tip prior to sterilization. Do not soak the scanner tips in disinfectant overnight. Dry the scanner tips thoroughly before mounting onto the scanner. Do not use an ultrasonic cleaning machine to clean the scanner tips. DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977M1)_RevisionE 11 Manually Cleaning the Scanner Tips To manually clean the scanner tips, follow these steps:

1 2 3 4 5 Rinse excess soil from the tip. Using a soft brush, apply an enzymatic detergent solution (e.g., Metrex EmPower) to all surfaces. Rinse under clean, running water. Inspect the tip. If the tip is not clean, repeat the steps. Use a lens tissue or lint-free cloth to remove any dust from the mirror in the tip. Cleaning the Scanner Tips in an Automatic Washer or Disinfector To clean the scanner tips in an automatic washer or disinfector, follow these steps:

1 2 3 4 5 6 Rinse excess soil from the tip. Using a soft brush, apply an enzymatic detergent solution (e.g., Metrex EmPower) to all surfaces. Load the tip into the washer/disinfector equipment. Run the cycle per the equipment manufacturers instructions. If the machine does not have an automatic rinse cycle, rinse thoroughly to remove detergent residues by immersing in clean water. Use a lens tissue or lint-free cloth to remove any dust from the mirror in the tip. 12 Chapter 1 Safety Information Sterilizing the Scanner Tips Note: If you limit the exposure time at 134C to not more than 4 minutes, you can autoclave the tip up to 110 cycles. To sterilize the cleaned scanner tips, follow these steps:

1 Place the tip in an FDA-cleared or CE-marked sealed sterilization pouch. The pouch should be sealed air-tight. Use either a self-adhesive pouch or a heat-sealed pouch. 2 Place the tips in a steam autoclave for the following times:

Pre-Vacuum Autoclave (Class B) Exposure Time at 132C Exposure Time at 134C Minimum Drying Time Minimum 4 Minutes Minimum 3 Minutes 20-30 Minutes Gravity Autoclave (Class N) Exposure Time at 132C Exposure Time at 134C Minimum Drying Time Minimum 15 Minutes Minimum 10 Minutes 15-30 Minutes Important: Do NOT exceed 134C. DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977M1)_RevisionE 13 Precautions Before Use Perform the following activities on your product and accessories before use. Cleaning, Disinfecting, and Sterilizing To ensure maximum hygienic safety for the patient and to minimize the risk of cross-contamination, carefully perform the following maintenance activities on your scanner and accessories. After each patient:

Clean and disinfect the scanner. See Cleaning and Disinfecting the Scanner on page 7. Clean and sterilize the scanner tip. See Cleaning and Sterilizing the Scanner Tips on page 10. Visually Inspecting the Scanner Visually inspect the scanner for damage or signs of deterioration by doing the following:

Inspect the scanner's lens window. Inspect around the scanner buttons and battery contact points (IS 3800W only). If damage is noted, do not use the scanner and contact your representative or the manufacturer. If any substance is noted around contact points, remove it with a dry cloth before use. Visually Inspecting the Scanner Tips Visually inspect the scanner tips for signs of deterioration by doing the following:

Verify that the tip is not damaged and its components are not detached. Verify that the tip mirror does not have any smudges or scratches on it. If deterioration is noted, replace the tip. WARNINGS The lens window on the scanner is a delicate optical component. Mount the front protective cover to protect the lens window from damage and dirt when the scanner is not in use. 14 Chapter 1 Safety Information The mirror in the tip is a delicate optical component. Its clean and undamaged surface is critical to scan quality. Make sure the contact points on the IS 3800W handpiece, battery, and charging station are clean and dry in order to avoid the risk of a short circuit. In the event that you see poor scan quality or an unclear video preview in the software, clean the tip mirror and the scanner's lens window using a microfiber cleaning swab, applying ethanol that is free of impurities. Marking and Labeling Symbols Type BF applied part symbol classification in accordance with IEC 60601 standards. Class II equipment In the European Union, this symbol indicates: DO NOT discard this product in a trash receptacle; use an appropriate recovery and recycling facility. Contact your local sales representative for additional information on the collection and recovery programs available for this product. Manufacturers address Manufactured date CAUTION:

Consult accompanying documentation. Refer to instruction manual/booklet. Direct current DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977M1)_RevisionE 15 Medical device Name of the European authorized representative and address of the registered place of business. Name of the Responsible Person in the United Kingdom and address of the registered place of business. Label Locations IS 3800W Labels The following figures illustrate the label locations of the IS 3800W. Figure 9 IS 3800W Box Label 16 Chapter 1 Safety Information Figure 10 IS 3800W Scanner Label DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977M1)_RevisionE 17 Figure 11 IS 3800W Charge Station Labels 18 Chapter 1 Safety Information Figure 12 IS 3800W Battery Charge Station Label Figure 13 IS 3800W Battery Label DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977M1)_RevisionE 19 IS 3800 Labels The following figures illustrate the label locations of the IS 3800. Figure 14 IS 3800 Box Label Figure 15 IS 3800 Scanner Label 20 Chapter 1 Safety Information Figure 16 IS 3800 Detachable Cable Label DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977M1)_RevisionE 21 22 Chapter 1 Safety Information 2 Regulatory Information General Regulatory Information Compliance with European and International Standards EN 60601-1 / IEC 60601-1 Medical Electrical Equipment, Part 1:

General Requirements for Basic Safety and Essential Performance EN 60601-1-2 / IEC 60601-1-2 IEC 60601-2-18 EN 62471 / IEC 62471 EN ISO 17664 EN 60601-1-6 / IEC 60601-1-6 Medical Electrical Equipment, Part 1-2:

General requirements for basic safety and essential performance Collateral Standard: Electromagnetic disturbances Requirements and tests Medical Electrical Equipment, Part 2-18:

Particular requirements for the basic safety and essential performance of endoscopic equipment Photobiological safety of lamps and lamp systems: Equipment classification, requirements, and Users Guide Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices Medical Electrical Equipment, Part 1-6:

General requirements for basic safety and essential performance - Collateral Standard: Usability EN/IEC 62366-1 Medical Devices Part 1: Application of usability engineering to medical devices EN 62304 / IEC 62304 Medical device software - Software life cycle Processes IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977M1 23 Compliance with European and International Standards EN ISO 10993-1 EN ISO 14971 EN ISO 15223-1 Biological evaluation of medical devices -

Part 1: Evaluation and testing within a risk management process Medical devices - Application of risk management to medical devices Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1:

General requirements EN 1041 Information supplied by the manufacturer of medical devices CAN/CSA-C22.2 No. 60601-1 Medical Electrical Equipment - Part 1:

General requirements for basic safety and essential performance ANSI/AAMI ES60601-1 Medical Electrical Equipment - Part 1:

EN 62133 EN 50566 General requirements for basic safety and essential performance Secondary cells and batteries containing alkaline or other non-acid electrolytes. Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications Product standard to demonstrate the compliance of wireless communication devices with the basic restrictions and exposure limit values related to human exposure to electromagnetic fields in the frequency range from 30 MHz to 6 GHz:

hand-held and body mounted devices in close proximity to the human body. 24 Chapter 2 Regulatory Information Compliance with European and International Standards EN 301 489-1 EN 301 489-17 EN 301 893 Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements; Harmonized Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU and the essential requirements of article 6 of Directive 2014/30/EU Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 17: Specific conditions for Broadband Data Transmission Systems;

Harmonized Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU 5GHz RLAN; Harmonized Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU Classification in Accordance with EN/IEC 60601-1 Type of protection against electric shock Degree of protection against electric shock Class II equipment Type BF Applied Part Mode of operation Continuous operation Flammable anesthetics Not suitable for use in the presence of flammable anesthetics or a mixture of flammable anesthetics with air or oxygen or nitrous oxide. DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977M1)_RevisionE 25 Conformity with EN/IEC 60601-1-2 IEC 60601-1-2: 2014 EMC requirements and t ests, Medical Electrical Equipment including CISPR 11:2009+A1:2010 Group 1, Class B. Electromagnetic Compatibility Precautions Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC). Medical equipment must be installed and put into service according to the EMC information provided in this documentation. Other equipment can interfere with communications with the IS 3800 Family, even if the equipment complies with CISPR emissions requirements. Warning: Portable and mobile RF communications equipment

(including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the CS 3800 Family of intraoral scanners, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. WiFi This equipment complies with radio frequency exposure limits set forth by the RED, the FCC, and Innovation, Science and Economic Development Canada for an uncontrolled environment. This device complies with part 15 of the FCC Rules and contains license exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canadas license-exempt RSS(s). Operation is subject to the following two conditions:

This device may not cause interference. This device must accept any interference, including interference that may cause undesired operation of the device. NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. 26 Chapter 2 Regulatory Information SAR Value for IS 3800W Handpiece:

5150-5250MHz 0.803W/kg 1g-SAR 5250-5350MHz 0.147W/kg 1g-SAR 5470-5725MHz 0.329W/kg 1g-SAR 5725-5850MHz 0.629W/kg 1g-SAR Caution: Changes or modifications to this unit not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. Limited by local law regulations, the version for North America does not have a region selection option. The device is for indoor use only and operates in the 5150-5250 MHz band to reduce the potential for harmful interference to co-channel mobile satellite systems. Guidance and Manufacturers Declarations Guidance and Manufacturers Declaration -

Electromagnetic Immunity (IEC 60601-1-2) The IS 3800 Family is intended for use in the electromagnetic environment specified below. The customer or user of the IS 3800 Family should assure that it is used in such an environment. Emissions Test Complianc e RF Emissions CISPR 11 Group 1 Electromagnetic Environment - Guidance The IS 3800 Family uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF Emissions CISPR 11 Class B Class A Complies Harmonic Emissions IEC 61000-3-2 Voltage Fluctuations/

Flicker Emissions IEC 61000-3-3 The IS 3800 Family is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977M1)_RevisionE 27 Electromagnetic Immunity for Equipment and Systems Fully Compliant with IEC 60601-1-2: 2014 The IS 3800 Family is intended for use in the electromagnetic environment specified below. The customer or the user of the IS 3800 Family should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance Electrostatic discharge

(ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11 Power frequency

(50/60 Hz) magnetic field IEC 61000-4-8 8 kV contact 15 kV air 8 kV contact 15 kV air 2 kV for power supply lines 2 kV for power supply lines Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. 1 kV line to line 1 kV line to line Mains power quality should 0% UT; 0,5 cycle At 0, 45, 90, 135, 180, 225, 270, and 315 0% UT; 1 cycle and 70% UT; 25/30a cycles Single phase: at 0 0% UT;

250/300a cycles 0% UT; 0,5 cycle At 0, 45, 90, 135, 180, 225, 270, and 315 0% UT; 1 cycle and 70% UT; 25/30a cycles Single phase: at 0 0% UT; 250/300a cycles 30 A/m 30 A/m be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the IS 3800 Family requires continued operation during power mains interruptions, it is recommended that the IS 3800 Family be powered from an uninterruptible power supply or a battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. a) e.g., 10/12 means 10 periods at 50 Hz or 12 periods at 60 Hz. NOTE: UT is the a.c. mains voltage prior to application of the test level. 28 Chapter 2 Regulatory Information Guidance and Manufacturers Declaration -

Electromagnetic Immunity (IEC 60601-1-2) The IS 3800 Family is intended for use in the electromagnetic environment specified below. The customer or the user of the IS 3800 Family should assure that it is used in such an environment. Immunity Test Conducted RF IEC 61000-4-6 IEC 60601 Test Level Electromagnetic Environment - Guidance 3 Vrms 150 kHz to 80 MHz Environment of a professional healthcare facility. 6 Vrms in ISM bands between 150 kHz and 80 MHza Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.7 GHz WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the IS 3800 Family including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. NOTE: Field strengths from fixed transmitters, such as base stations for radio

(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the IS 3800 Family is used exceeds the applicable RF compliance level above, the IS 3800 Family should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the IS 3800 Family. a The ISM (industrial, scientific and medical) bands between 150 k Hz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977M1)_RevisionE 29 Guidance and Manufacturers Declaration -

Electromagnetic Immunity For the immunity to proximity fields from RF wireless communications equipment, the IS 3800 Family is compliant with the test levels specified below, according to IEC60601-1-2 standard. The customer or user of the IS 3800 Family should assure that it is used in such an environment. Test Frequency

(MHz) Band (MHz) Immunity Test Levels 380-390 Pulse modulation 18Hz, 27V/m 430-470 FM, 5 kHz deviation, 1 kHz sine, 28V/m 704-787 Pulse modulation 217Hz, 9V/m 800-960 Pulse modulation 18Hz, 28V/m 1700-1990 Pulse modulation 217Hz, 28V/m 2400-2570 Pulse modulation 217Hz, 28V/m 5100-5800 Pulse modulation 217Hz, 9V/m 385 450 710 745 780 810 870 930 1720 1845 1970 2450 5240 5500 5785 30 Chapter 2 Regulatory Information Compliance with International Regulations Medical Device Regulation (EU) 2017/745 FDA Center for Devices & Radiological Health CDRH - Title 21 CFR 872.3661 (USA) Medical Devices Regulations (Canada) Directive 2011/65/EU on the Restriction Of the use of certain Hazardous Substances in electrical and electronic equipment

(ROHS), as amended by Directive (EU) 2015/863 Radio Equipment Directive 2014/53/EU (IS 3800W only) Medical Devices Regulations 2002 (SI618) as subsequently amended by the EU Exit Regulations of 2019 (SI 791) and 2020

(SI 1478). DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977M1)_RevisionE 31 32 Chapter 2 Regulatory Information 3 Technical Specifications Factory Rayco (Shanghai) Medical Products Company Limited Building 7, No. 1510 Chuanqiao Road China (Shanghai) Pilot Free Trade Zone 201206 Shanghai PEOPLE'S REPUBLIC OF CHINA Manufacturer Dental Imaging Technologies Corporation 450 Commerce Drive Quakertown, PA USA 18951 Model IS 3800W IS 3800 DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977M1)_RevisionE 33 IS 3800 Family Technical Specifications IS 3800W Components Technical Specifications Sensor technology CMOS Illumination LED: Red, Blue, Green Field of view 16 x 14 mm 13 x 7 mm (posterior tip) Depth of field

-2 to +16 mm Anti-fogging technology Digital connection Handpiece dimensions By airflow WiFi 5GHz, 802.11ac 226 x 38 x 50 mm

(with normal/side tip) Components Technical Specifications Weight 240 g (with battery) Handpiece Input: 5 V 5A (with backup power cable) 4.2 V 3A (with battery) Handpiece Charger Input: 12 V 2.5A Output 1 (charging port): 4.2 V 3A Output 2 (port for backup power cable): 12 V 2.5A Battery Charger Input: 12V 2.5A Output: 4.2V 3A Note: When charging a single battery, the output is 3A. When charging two batteries at the same time, the output of each slot is limited to 2.4A, to prevent the power adapter from being overloaded. 34 Chapter 3 Technical Specifications Battery Adapter Model: 1INR18/65 3.6 V/3500 mAh Model: LXCP30A-120 Input: 100-240V ~ 50/60Hz, 0.8A Max Output: 12.0V 2.5A Backup Power Cable Length: 2 m IS 3800 Components Technical Specifications Sensor technology CMOS Illumination LED: Red, Blue, Green Field of view 16 x 14 mm 13 x 7 mm (posterior tip) Depth of field

-2 to +16 mm Anti-fogging technology By airflow Detachable cable Interface: USB Type-C Length: 2 m USB 3.1 229 x 38 x 50 mm

(with normal/side tip) Digital connection Handpiece dimensions without cable Components Technical Specifications Weight Handpiece 190g (with normal/side tip, no cable) Input: 5 V 3A DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977M1)_RevisionE 35 Length of Cables Supplied with the Unit Illustration of Part IS 3800W Part Name Length of Cable (m) Backup Power Cable 2.0 m AC Adapter 1.8 m Illustration of Part IS 3800 Part Name Length of Cable (m) Detachable Cable 2.0 m 36 Chapter 3 Technical Specifications IS 3800 Family Environmental Requirements Components Environmental Requirements Operating Temperature +5 ~ 30 C Transportation and Storage Temperature

-10 ~ 50 C Operating Relative Humidity Transportation and Storage Relative Humidity 10 85% RH 10 95% RH Operating Atmospheric Pressure 700 1060 hPa Transportation and Storage Atmospheric Pressure 600 1060 hPa Computer System Requirements If necessary, you must update your computer system configuration. Item Recommended Minimum CPU Intel Core i7, 9th generation Laptop: Intel Core i7-7700HQ, Quad CPU, 2.8 GHz RAM 32 GB RAM 16 GB RAM Monitor Screen resolution: 1920 X 1080 Screen resolution: 1920 X 1080 Operating system Windows 10 Professional, version 1809 or higher Windows 10 Professional, version 1809 or higher USB port USB 3.0 for WiFi adapter (IS 3800W) USB 3.0 for WiFi adapter (IS 3800W) USB Type-C (IS 3800) USB Type-C (IS 3800) Video card NVIDIA GeForce RTX 2060, 6 GB memory NVIDIA GeForce GTX 1050 Ti or Quadro P3000 or similar Video card driver Support OpenGL 4.3 and OpenCL 1.1 Support OpenGL 4.3 and OpenCL 1.1 DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977M1)_RevisionE 37 Note: The All-In-One computer system requirement is an exception. The computer and its screen should be situated in or close to the operating area, in the visual field of the practitioner when using the IS 3800 Family. Important: It is MANDATORY to check that your system configuration is compatible with the computer system requirements for the IS 3800 Family software. Note: Always use Microsoft Windows Update to ensure that the latest security patches are correctly installed. 38 Chapter 3 Technical Specifications 4 Contact Information Manufacturers Address Dental Imaging Technologies Corporation 450 Commerce Drive Quakertown, PA USA 18951 European Community EC REP PaloDEx Group Oy Nahkelantie 160 04300 Tuusula, FINLAND UK Responsible Person Kerr UK Limited c/o Orega Stockley Park 4 Longwalk Road Stockley Park Uxbridge UB11 1FE United Kingdom List of Importers for European Union According to the MDR 2017/745 PaloDEx Group Oy Nahkelantie 160 04300 Tuusula, FINLAND DEXIS IS 3800 Family Safety, Regulatory, and Technical Specifications User Guide (TA3977M1)_RevisionE 39 2023 Dental Imaging Technologies Corporation RevisionE 2023-09

Dental Imaging Technologies Corporation 450 Commerce Drive Quakertown, PA USA 18951 Authority to Act as Agent Date: November 21, 2023 American Certification Body, Inc. 313 Park Avenue Suite 300 Falls Church, VA 22046 To Whom It May Concern:

______Intertek Testing Services Shanghai______ is authorized to act on our behalf, until otherwise notified, for applications to American Certification Body, Inc. (ACB). We certify that we are not subject to denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862. Further, no party, as defined in 47 CFR 1.2002 (b), to the application is subject to denial of federal benefits, that includes FCC benefits. We also declare that the information provided to the FCC is true and correct to the best of our knowledge (47 CFR 2.911(d)) and we have been informed of the grantee responsibilities (47 CFR 2.909) with regard to certified equipment. Thank you, Agency Agreement Expiration Date: _____November 16, 2024____ By:

(Signature) ________Sam Qian ________

(Print name) Title:

______ Project Manager ______ On behalf of: _____Dental Imaging Technologies Corporation______

(Company Name) Telephone:

______888.883.3947 __________________________ 050222-17

Dental Imaging Technologies Corporation 450 Commerce Drive Quakertown, PA USA 18951 Date: November 21, 2023 Request for Confidentiality Subject: Confidentiality Request for: ______(FCC ID:2A7FYIS3800W and IC:28659-IS3800W)______ Pursuant to FCC 47 CFR 0.457(d) and 0.459 and/or IC RSP-100, Section 12.4, the applicant requests that a part of the subject application(s) be held confidential. Type of Confidentiality Requested Short Term Short Term Short Term Short Term Short Term Short Term Short Term Short Term Short Term Permanent

Permanent *1 Permanent Permanent Permanent Permanent

Permanent *1 Exhibit Block Diagrams External Photos Internal Photos Operation Description/Theory of Operation Parts List & Placement/BOM Tune-Up Procedure Schematics Test Setup Photos Users Manual Dental Imaging Technologies Corporation has spent substantial effort in developing this product and it is one of the first of its kind in industry. Having the subject information easily available to "competition" would negate the advantage they have achieved by developing this product. Not protecting the details of the design will result in financial hardship. Permanent Confidentiality:

The applicant requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Short-Term Confidentiality for FCC Applications:

The applicant requests the exhibits selected above as short term confidential be withheld from public view for a period of __ (specify number of days not to exceed 180)2___ days from the date of the Grant of Equipment Authorization and prior to marketing. This is to avoid premature release of sensitive information prior to marketing or release of the product to the public. Applicant is also aware that they are responsible to notify ACB in the event information regarding the product or the product is made available to the public before the requested period has expired. ACB will then release the documents listed above for public disclosure pursuant to FCC Public Notice DA 04-1705. Short Term Confidentiality for Industry Canada Applications:

Starting May 2022, ISED will recognize short term confidentiality on certain exhibits until the intended date of marketing. The applicant requests the exhibits selected above as short term confidential be withheld from public view until:

(specify ISED expiration date / date of marketing) . Sincerely, By:

_____________/ Project Manager_____________ Sam Qian

(Signature/Title3)

(Print name) 1 - The asterisked items (*) require further information to be provided to ACB before permanent confidentiality will be extended to these exhibits. Please refer to FCC KDB 726920 and the specific Document link for D01 found at:

https://apps.fcc.gov/oetcf/kdb/forms/FTSSearchResultPage.cfm?switch=P&id=41731 and review section II, 3) regarding specific information that must accompany these requests. 2 - Please refer to https://acbcert.com/documents/misc-docs/Memo-Short-Term-Vs-Standard-Confidentiality.pdf for complete details. 3 - Must be signed by applicant contact given for applicant on the FCC site, or by the authorized agent if an appropriate authorized agent letter has been provided. Letters should be placed on appropriate letterhead. 050222-17

Dental Imaging Technologies Corporation 450 Commerce Drive Quakertown, PA USA 18951 Certification Application Attestation Statements Date: November 21, 2023 American Certification Body, Inc. 313 Park Avenue Suite 300 Falls Church, VA 22046 To Whom It May Concern:

Statement for 47 CFR section 2.911(d)(5)(i) Dental Imaging Technologies Corporation certifies that as of the date of the application the equipment for which authorization is sought is not covered equipment1 prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. If the equipment for which the applicant seeks authorization is produced by any of the entities identified on the current Covered List, including affiliates or subsidiaries of the named companies, the applicant must include an explanation on why the equipment is not covered equipment. Additional Explanation: <N/A>

Statement for 47 CFR section 2.911(d)(5)(ii) Dental Imaging Technologies Corporation (the applicant) certifies that, as of the date of the filing of this application, the applicant is not identified on the Covered List as an entity producing covered equipment. Thank you, By:

(Signature) ______ Sam Qian______

(Print name) Title:

________ Project Manager______ Company:

Dental Imaging Technologies Corporation Telephone:

888.883.3947 1 - The Commissions Covered List is published by the Public Safety and Homeland Security Bureau and posted on the Commissions website. This Covered List, which is periodically updated, identifies particular equipment, produced by particular entities, that constitutes covered equipment. https://www.fcc.gov/supplychain/coveredlist . 050523-17 rev 8

Dental Imaging Technologies Corporation 450 Commerce Drive Quakertown, PA USA 18951 U.S. Agent Designation for Service of Process

(Applicant is Both Grantee and U.S. Agent) TO: American Certification Body, Inc. 313 Park Avenue Suite 300 Falls Church, VA 22046 ATTENTION: FCC Certification Section 2.911(d)(7) Information This letter is to confirm that the Applicant will also serve as the U.S. Agent for Service of Process as required by 47 CFR 2.911(d)(7). The Applicant acknowledges that they must maintain an agent for no less than one year after terminating all marketing and importation OR the conclusion of any Commission-related proceeding involving the equipment. The Applicant further acknowledges their responsibility to inform the FCC whenever the Designated U.S. Agent information changes. Applicant Company name: Dental Imaging Technologies Corporation Grantee Code: 2A7FY FRN #:0032547317 Contact Name: Sam Qian Street Address: 450 Commerce Drive Quakertown City/Province/Zip: PA USA 18951 Telephone No: 888.883.3947 Email: Dijun.qian@envistaco.cn Applicant Signature:

Date: 2023/11/21 Signed by (Printed Name/Title): Sam Qian / Project Manager

Dental Imaging Technologies Corporation 450 Commerce Drive Quakertown, PA USA 18951 Attention: Application Examiner/Reviewe Engineer Reference:

Class II permissive chagne for FCC ID: 2A7FYIS3800W Dear Examiner, This is to request for Class II permissive change for FCC ID: 2A7FYIS3800W originally granted on 2022.09.09. This application is based on: The frequency bands supported by the device is added through the software upgrade without hardware changes. Original application frequency band:

5150 - 5250MHz 802.11ac (VHT80) only. New applicantion frequency band:

5150 - 5250MHz, 5250 - 5350 MHz, 5470 - 5725 MHz, 5725 - 5850 MHz 802.11ac (VHT20), 802.11ac (VHT40), 802.11ac (VHT80) Signature:

Printed signature: Sam Qian Title: Project Manager Date: November 21, 2023

DENTAL IMAGING TECHNOLOGIES CORPORATION 450 Commerce Drive Quakertown, PA 18951 Attention: Application Examiner / Review Engineer Subject: Request to change in identification per section 2.933 of FCC rules and Multiple Listing of Certification service per clause 11.5 of RSP-100 Reference: FCC ID: 2A7FYIS3800W and IC: 28659-IS3800W Statement from applicant On the behalf of DENTAL IMAGING TECHNOLOGIES CORPORATION I am writing to apply for certification of the following product from our company:

Grantee name: DENTAL IMAGING TECHNOLOGIES CORPORATION Model / HVIN & PMN name: IS 3800W FCC ID: 2A7FYIS3800W IC: 28659-IS3800W The above product, for which we are applying for certification, is identical to the following product:

Grantee name: Carestream Dental, LLC. Granted date of FCC and IC: 06/03/2021 and 06/10/2021 Model / HVIN & PMN name: CS 3800 Wireless, Trophy 3800 Wireless Original FCC ID: 2ASFG-CS3800 Original IC: 24914-CS3800 in design, circuitry and construction except for trade name, model number and logo. The documents on file with FCC/ISED from the original certification remain unchanged and continue to be valid, except for user manual and label location. As a result, the original test results of above FCC ID and IC granted product continue to be representative of and applicable to the product from our company for certification. Date: June 22, 2022

Signed by original applicant Title: Product Manager Telephone: +86-135-2413-9237 On behalf of: ____ DENTAL IMAGING TECHNOLOGIES CORPORATION _____

(Company Name)

DocuSign Envelope ID: 0F53C3C6-8E85-40E6-833B-EB400E34E4A8 Carestream Dental LLC 3625 Cumberland Blvd, Ste 700, Atlanta, GA 30339 Attention: Application Examiner / Review Engineer Subject: Authorization for changing FCC / IC identifier Reference: FCC ID: 2A7FYIS3800W and IC: 28659-IS3800W On the behalf of Carestream Dental LLC (original Grantee / certificate holder), I authorize the following Grantee name: Carestream Dental LLC Granted date of FCC and IC: 06/03/2021 and 06/10/2021 Model / HVIN & PMN name: CS 3800 Wireless, Trophy 3800 Wireless Original FCC ID: 2ASFG-CS3800 Original IC: 24914-CS3800 to be changed FCC / IC identifier as:

Grantee name: DENTAL IMAGING TECHNOLOGIES CORPORATION Model / HVIN & PMN name: IS 3800W FCC ID: 2A7FYIS3800W IC: 28659-IS3800W It was authorized DENTAL IMAGING TECHNOLOGIES CORPORATION to use documents among the existing FCC and IC certification for Multiple Listing of Certification / identification change. The new product should be same as the one from my company in design, circuitry and construction except for trade name, model number and logo.

Signed by original applicant Name: Jeremy Thomas Title: Manager On behalf of: Carestream Dental LLC

(Company Name) Telephone: +33 1 64 80 85 80

Dental Imaging Technologies Corporation 450 Commerce Drive Quakertown, PA USA 18951 Authority to Act as Agent Date: June 30, 2022 American Certification Body, Inc. 6731 Whittier Avenue Suite C110 McLean, VA 22101 To Whom It May Concern:

Intertek Shanghai is authorized to act on our behalf, until otherwise notified, for applications to American Certification Body, Inc. (ACB). We certify that we are not subject to denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862. Further, no party, as defined in 47 CFR 1.2002 (b), to the application is subject to denial of federal benefits, that includes FCC benefits. We also declare that the information provided to the FCC is true and correct to the best of our knowledge (47 CFR 2.911(d)) and we have been informed of the grantee responsibilities (47 CFR 2.909) with regard to certified equipment. Thank you, Agency Agreement Expiration Date: Dec 30, 2022 By:

(Signature1) _Qian, Sam __ _____

(Print name) Title:

______Product Manager______ On behalf of: ____ Dental Imaging Technologies Corporation_____

(Company Name) Telephone:

(+86) 13524139237 1 - Must be signed by applicant contact given for applicant on the FCC site, or by the authorized agent if an appropriate authorized agent letter has been provided. Letters should be placed on appropriate letterhead.