(266 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description indicates it primarily relies on electricity, compressed air, and water for its functions, without any mention of AI capabilities.
No.
The device is a dental unit that supplies power to and serves as a base for other dental devices and accessories; it does not directly provide therapeutic treatment itself.
No
The dental unit is described as supplying power to and serving as a base for other dental devices and accessories, and providing general dental treatment functions, and does not mention any diagnostic capabilities.
No
The device is described as a physical dental unit with various hardware components like a dental chair, instrument tray, lights, and suction systems. It relies on electricity, compressed air, and water. While it mentions "Software Verification and Validating Testing," this indicates software exists within a physical medical device, not that the device itself is software-only.
No.
The device is a dental unit that provides power and serves as a base for dental devices. It does not perform tests on samples from the human body.
No.
The clearance letter does not mention a Predetermined Change Control Plan (PCCP) and the "Predetermined Change Control Plan (PCCP) - All Relevant Information" section explicitly states "Not Found".
Intended Use / Indications for Use
The Dental Unit is intended to supply power to and serve as a base for dental devices, and accessories. It is intended for use in the dental clinic /office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.
Product codes
EIA, KLC
Device Description
The Integral dental unit is a dental treatment unit tested in accordance with IEC 80601-2-60. This product is used in dentistry only and may only be used by trained medical personnel and trained professionals in the field of general dentistry. The Integral dental unit consists of a dental chair, side box, dental light, instrument tray, 3-way syringe, strong suction, weak suction, cuspidor, x-ray film viewer, and the wired foot pedal. Optional accessories include ultrasonic scalers, curing lights, dental handpieces and dental electrical motor, which are to be purchased by the user. The dental operative unit is equipped with a dental light and water heater. The dental operative unit mainly relies on electricity, compressed air, water to achieve all functions. Various ancillary dental devices can be connected to the Integral dental unit which are attached by means of industry standard ISO connections. The ancillary dental devices include 3-way syringe, strong suction and weak suction vacuum instruments are manufactured by the Mipont Medical Equipment Co., Ltd. None of the Integral dental unit parts or accessories are provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained dentists and/or dental technicians and assistants. This product is attached with a dental chair. It is intended for use in the dental clinic /office environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Electrical safety (IEC60601-1:2005+A1:2012+A2:2020, ANSI AAMI ES60601-1:2005 + C1:2009 + A2:2010 + A1:2012 + A2:2021)
- Electromagnetic compatibility (EMC) (IEC 60601-1-2:2014 /AMD1:2020, IEC TR 60601-4-2:2016)
- Basic Safety and Essential Performance (IEC 60601-1-6:2010+A1:2013+A2:2020, IEC 62366-1 Edition 1.0 2015-02, IEC 80601-2-60:2019, ISO 7494-1:2018, ISO 7494-2:2022, ISO 9680:2021)
- Software Verification and Validating Testing
- Biocompatibility testing (ISO 10993-5:2019, ISO 10993-10:2021, ISO 10993-23:2021)
- Sterilization and Shelf Life & Packaging testing (ISO 17665-1:2006, ASTM D4169-22)
No clinical testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 27, 2025
Mipont Medical Equipment Co., Ltd.
Chen Salon
System Engineer
No.101, No.201, No.203, Building 1, Guangming Technology Pk
Lanhe Avenue, Lanhe, Nansha
Guangzhou, 511480
CHINA
Re: K242611
Trade/Device Name: Integral Dental Units
Regulation Number: 21 CFR 872.6640
Regulation Name: Dental Operative Unit And Accessories
Regulatory Class: Class I, reserved
Product Code: EIA, KLC
Dated: April 8, 2025
Received: April 25, 2025
Dear Chen Salon:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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K242611 - Chen Salon Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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K242611 - Chen Salon Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
MICHAEL E. ADJODHA -S
Michael E. Adjodha, MChE, RAC, CQIA
Assistant Director
DHT1B: Division of Dental and ENT Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known)
K242611
Device Name
Integral Dental Units
Indications for Use (Describe)
The Dental Unit is intended to supply power to and serve as a base for dental devices, and accessories. It is intended for use in the dental clinic /office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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K242611 - 510(k) Summary
Page 1
1. Submitter's Identification:
- Company Name: Mipont Medical Equipment Co., Ltd.
- Address: No.101, No.201, No.203, Building 1, Guangming Technology Park, No. 105, Lanhe Avenue, Lanhe, Nansha, Guangzhou, China
- Phone: +86-020-39142110
- Fax: +86-020-89887711
- Contact Person (Title): Calvin Chen (General Manager)
- E-mail：official@gzfengdan.com
- Date of Preparation: May 22, 2025
2. Application Correspondent
- Company Name: IMD Medical & Drug technology service institutions
- Phone: +86-18613190779
- Fax: +86-755-62809168
- Contact Person (Title): Salon Chen (System engineer)
- E-mail：33999439@qq.com
- Address: Room 308, Building 11, No. 23 Jinqu Road, Wanjiang District, Dongguan City, Guangdong Province, China
3. Name of the Device:
- Name: Integral Dental Units
- Model: M100, M200, M300, M500, B100, B200, B300, B500
4. Common Name and Classification:
- Device Classification Name: Dental operative unit and accessories
- Classification Product Code: EIA
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- Regulation Number: 872.6640
- Class: Class I
- Review Panel: Dental
5. Predicate Device 1 Information:
- 510(k) Number: K231845
- Device Classification Name: Dental operative unit and accessories
- Sponsor: Foshan Safety Medical Equipment Co., Ltd.
- Classification Product Code: EIA
- Regulation Number: 872.6640
- Class: Class I
- Review Panel: Dental
- Trade/Proprietary Name: Dental Unit, model: Mare
6. Predicate Device 2 Information:
- 510(k) Number: K233921
- Device Classification Name: Dental operative unit and accessories
- Sponsor: DENTIS CO., LTD.
- Classification Product Code: EIA
- Regulation Number: 872.6640
- Class: Class I
- Review Panel: Dental
- Trade/Proprietary Name: Luvis Chair (LC700C)
7. Device Description
The Integral dental unit is a dental treatment unit tested in accordance with IEC 80601-2-60. This product is used in dentistry only and may only be used by trained medical personnel and
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trained professionals in the field of general dentistry. The Integral dental unit consists of a dental chair, side box, dental light, instrument tray, 3-way syringe, strong suction, weak suction, cuspidor, x-ray film viewer, and the wired foot pedal. Optional accessories include ultrasonic scalers, curing lights, dental handpieces and dental electrical motor, which are to be purchased by the user. The following accessories are recommended for use with the Integral dental unit:
| Device | 510(k) Number | Manufacturer |
|---|---|---|
| Ultrasonic Scaler | K053555 | Guilin Woodpecker Medical Instrument Company, Limited |
| Curing Light | K243921 | Foshan COXO Medical Instrument Co., Ltd. |
| Pneumatic Handpiece | K170229, K170236 | GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD |
| Dental motor | K203706 | Guilin Woodpecker Medical Instrument Co., Ltd. |
The dental operative unit is equipped with a dental light and water heater, with specifications shown in the following tables.
Dental Light Specification
| Items | Specification |
|---|---|
| Weight | 2.20kg |
| Light source | 8 white light emitting diodes (LEDs) (the middle 4 white light emitting diodes (LEDs) can be switched to yellow light |
| illuminance | Under normal mode adjustable from 40000 lux to ISO 9680. Under white and yellow mixed light mode,15000,20000,25000 lux, 3 levels adjustable, according to ISO 96680:2014 |
| Resin safety function | Use touch switch to switch to the composite function |
| Color temperature | Under normal 5000K~5700K, Under white and yellow mixed light mode 4000K |
| Color Rendering Index (Ra) | ≥90 |
| Unit model power connection | AC 24V |
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| Dimension of Light head, Movement and installation interface | [Technical diagrams shown] |
|---|---|
| Illuminance diagram | [Technical diagram shown] |
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Water Heater Specification
| Items | Specification |
|---|---|
| Voltage and Power | AC24V 80-90W |
| Heating Method | Heating Coil |
| Storage Container Temperature | Max. 40℃ |
| Temperature | Max. 40℃ |
| Water Temperature: | Avg. 33 ~ 35℃ |
| Temperature Sensor | Bi- metallic Thermostats |
The dental operative unit mainly relies on electricity, compressed air, water to achieve all functions. Various ancillary dental devices can be connected to the Integral dental unit which are attached by means of industry standard ISO connections. The ancillary dental devices include 3-way syringe, strong suction and weak suction vacuum instruments are manufactured by the Mipont Medical Equipment Co., Ltd. None of the Integral dental unit parts or accessories are provided sterile.
[Note] Ancillary devices, such as dental pneumatic handpieces, are not included with this subject device. These optional device and accessories are not supplied with the subject device and are installed by the end-users using the recommended installation method described in the user manual provided by the manufacturers of these ancillary device. Also, the strong suction tip and weak suction tip are not included with the subject device and not provided with the subject device.
8. Indications for Use
The Dental Unit is intended to supply power to and serve as a base for dental devices, and accessories. It is intended for use in the dental clinic /office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.
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9. Comparison to the predicate device
Table 1 General Comparison
| Elements of Comparison | Proposed Device – K242611 | Predicate Device 1 – K231845 | Predicate Device 2 – K233921 | Judgement |
|---|---|---|---|---|
| Company Name | Mipont Medical Equipment Co., Ltd. | Foshan Safety Medical Equipment Co., Ltd. | DENTIS CO., LTD. | / |
| Device Name | Integral Dental Units | Dental Unit, model: Mare | Luvis Chair (LC700C) | / |
| Regulation Description | Dental operative unit and accessories | Dental operative unit and accessories | Dental operative unit and accessories | Same |
| Review Panel | Dental | Dental | Dental | Same |
| Classification Product Code | EIA | EIA | EIA | Same |
| Regulation Number | 872.6640 | 872.6640 | 872.6640 | Same |
| Class | Class I | Class I | Class I | Same |
| Prescription or OTC | Prescription Use | Prescription Use | Prescription Use | Same |
| Environment of Use | Dental clinic /office environment | Dental clinic /office environment | Dental clinic /office environment | Same |
| Intended Use | The Dental Unit is intended to supply power to and serve as a base for dental devices, and accessories. It is intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair. | The Dental Unit is intended to supply power to and serve as a base for dental devices, and accessories. It is intended for use in the dental clinic /office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair. | Luvis Chair is intended to supply power to and serve as a base for dental devices and accessories. This Device includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants. | Same |
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Table 2 Safety factor & Performance Comparison
| Safety factor & Performance | Proposed Device - K242611 | Predicate Device 1 – K231845 | Predicate Device 2 – K233921 | Judgement |
|---|---|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 | Compliance with IEC 60601-1 | Compliance with IEC 60601-1 | Same |
| EMC | Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1-2 | Same |
| Usability Engineering | Compliance with IEC 62366-1 | Unknown | Unknown | Note 1 |
| Software | Compliance with IEC 62304 | Compliance with IEC 62304 | Compliance with IEC 62304 | Same |
| Biocompatibility | Compliance with ISO 10993-1 | Compliance with ISO 10993-1 | Compliance with ISO 10993-1 | Same |
Features
| Operating Light | LED | LED | Available | Same |
|---|---|---|---|---|
| Connection Joint | Comply with ISO9168 | Comply with ISO9168 | Comply with ISO9168 | Same |
| Water Heating | Heating Method: Heating Coil Storage Container Temperature: Max. 40℃ Water Temperature: Avg. 33 ~ 35℃ Temperature Sensor: Bi-metallic Thermostats | No | Heating Method: Heating Coil Storage Container Temperature: Max. 40℃ Water Temperature: Avg. 33 ~ 35℃ Temperature Sensor: Bi-metallic Thermostats | Same |
| Operational Model | Control Panel / Assistant Control Panel / Foot Controller | Control Panel / Assistant Control Panel / Foot | / | Same |
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| Power Supply | 110V-240V | 110V | 100-120/220-240 V | Note 2 |
|---|---|---|---|---|
| Frequency | 50/60HZ | 60Hz | 50/60 Hz | Same |
| Power (with dental chair) | 260VA | 1100VA | / | Note 2 |
| Pressure of Water Supply | 200～400kPa | 200kPa-400kPa | 215kPa (Min) / 275kPa (Max) (2.5 ± 0.3 kgf/㎠) | Same |
| Pressure of Air Supply | ≥550kPa | ≥550 kPa | 500kPa (Min) / 750kPa (Max) | Same |
Dental Chair
| Loading Capacity | 150kg | 150kg | Max. 150 kg | Same |
|---|---|---|---|---|
| Movement Range (Chair) | 380-780mm | 420mm-820mm | / | Note 3 |
| Range of Angular Movement for Backrest | 2° ～ 67° | -5° ～ 85° | 0°±5° to 65°±5° | Note 3 |
| Movement Range (Backrest) | 150mm | 130mm | / | Note 3 |
| Attached Accessories | Handpiece/ Syringe | Handpiece/ Syringe | 1) Accessories: Suction (Saliva Ejector, HVE), Dry Air Syringe, 3-Way Syringe 2) Light On/Off, Cup/Spittoon Water Dispenser, Changing the Settings, Position Memories, 1 Person Helper System | Same |
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| Rate of Water Suction | Suction ≥ 1L/min | ≥ 1L/min | / | Same |
|---|---|---|---|---|
| Saliva Ejector > 400mL/min | > 750mL/min | / | Note 4 | |
| Performance Standards | Comply with ISO7494-1 and ISO7494-2 | Comply with ISO7494-1 and ISO7494-2 | Comply with ISO7494-1 and ISO7494-2 | Same |
Review of Differences：
Note 1
The subject device complies with the IEC 62366-1 usability requirement, whereas this information for both predicate devices is unknown. Despite this, the usability compliance ensures that the subject device is safe and effective for its intended use.
Note 2
The subject device and predicate device differ in the power supply. The subject device has demonstrated electrical safety by passing IEC 60601-1, IEC 60601-1-2, and IEC 80601-2-60 tests. Therefore, this difference does not affect the safety and effectiveness of the subject device compared to the predicate device.
Note 3
The subject device and predicate device (K231845) differ in the dental chair movement range and in range of angular movement for the backrest. The subject device has demonstrated compliance with the requirements by passing the ISO 7494-1:2018 test. Additionally, the subject device has shown electrical safety by passing IEC 60601-1, IEC 60601-1-2, and IEC 80601-2-60 tests. Therefore, this difference does not affect the safety and effectiveness of the subject device compared to the predicate device.
Note 4
The saliva ejector suction rate is > 400mL/min for the subject device, while it is > 750mL/min for the
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predicate device (K231845). The subject device has demonstrated compliance with relevant electrical safety standards, including IEC 60601-1, IEC 60601-1-2, and IEC 80601-2-60. This ensures that the decreased (relative to the predicate) suction capability does not introduce any additional electrical hazards. Therefore, this difference does not affect the safety and effectiveness of the subject device compared to the predicate device.
10. Discussion of Non-clinical Tests Performed for Determination of Substantial Equivalence are as follows:
A series of non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
1) Electrical safety
IEC60601-1:2005+A1:2012+A2:2020, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
ANSI AAMI ES60601-1:2005 + C1:2009 + A2:2010 + A1:2012 + A2:2021, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)].
2) Electromagnetic compatibility (EMC)
IEC 60601-1-2:2014 /AMD1:2020, Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests.
IEC TR 60601-4-2:2016, Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems.
3) Basic Safety and Essential Performance
IEC 60601-1-6:2010+A1:2013+A2:2020 Medical Electrical Equipment - Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability.
IEC 62366-1 Edition 1.0 2015-02: Medical Devices - Application of Usability Engineering to Medical Devices.
IEC 80601-2-60:2019 Medical electrical equipment - Part 2-60: Particular requirements for the
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basic safety and essential performance of dental equipment
ISO 7494-1:2018, Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements
ISO 7494-2:2022, Dentistry - Stationary dental units and dental patient chairs - Part 2: Air, water, suction and wastewater systems
ISO 9680:2021, Dentistry - Operating lights
4) Software Verification and Validating Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern.
5) Biocompatibility testing
ISO 10993-5:2019 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2021 Biological evaluation of medical devices - Parts 10: Tests for skin sensitization
ISO 10993-23:2021 Biological evaluation of medical devices-Parts 10: Tests for irritation
6) Sterilization and Shelf Life & Packaging testing
ISO 17665-1:2006, Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1
ASTM D4169-22, Standard Practice for Performance Testing of Shipping Containers and Systems.
11. Discussion of Clinical Accuracy Testing Performed
There was no clinical testing performed.
12. Conclusion
The subject devices have all features of the predicate devices. The few differences do not affect the safety and effectiveness of the subject devices. Thus, the subject devices are substantially equivalent to the predicate devices.