Integral Dental Units

K242611 · Mipont Medical Equipment Co., Ltd. · EIA · May 27, 2025 · Dental

Device Facts

• Record ID: K242611
• Device Name: Integral Dental Units
• Applicant: Mipont Medical Equipment Co., Ltd.
• Product Code: EIA · Dental
• Decision Date: May 27, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

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.

Device Story

Integral Dental Units serve as a base for dental procedures; provide power, water, and air to ancillary dental instruments (e.g., handpieces, scalers, curing lights). Components include dental chair, side box, LED dental light, instrument tray, 3-way syringe, suction systems (strong/weak), cuspidor, x-ray film viewer, and wired foot pedal. Operated by dentists/technicians in dental clinics. Device transforms electrical, pneumatic, and hydraulic inputs to support clinical tasks. Healthcare providers use the unit to position patients and manage instrument power/suction. Benefits include centralized control of dental equipment and patient positioning. No clinical data; bench testing only.

Clinical Evidence

No clinical data. Bench testing only. Verification included electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), usability (IEC 62366-1), biocompatibility (ISO 10993), and performance testing per ISO 7494-1/2 and ISO 9680.

Technological Characteristics

Stationary dental unit; AC 24V power; heating coil water heater with bi-metallic thermostats. LED dental light (8 LEDs, 5000K-5700K, Ra ≥90). Connectivity via industry standard ISO 9168 joints. Compliance with IEC 60601-1, IEC 60601-1-2, ISO 7494-1/2, ISO 9680. Software level of concern: Moderate.

Indications for Use

Indicated for use in dental clinic/office environments by trained dentists, dental technicians, and assistants to provide power and a base for dental devices and accessories.

Regulatory Classification

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.

Predicate Devices

• Dental Unit, model: Mare (K231845)
• Luvis Chair (LC700C) (K233921)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K242611 - Chen Salon
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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
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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)

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K242611 - 510(k) Summary

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: [phone]
> Fax: [phone]
> Contact Person (Title): Calvin Chen (General Manager)
> E-mail : [e-mail]
> Date of Preparation: May 22, 2025

2. Application Correspondent
> Company Name: IMD Medical & Drug technology service institutions
> Phone: [phone]
> Fax: [phone]
> Contact Person (Title): Salon Chen (System engineer)
> E-mail : [e-mail]
> 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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```markdown
- 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 < 8000 to > 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 | |
| --- | --- |
| Illuminance diagram | |

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| Water Heater Specification | |
| --- | --- |
| Items | Specification |
| Voltage and Power | AC24V 80-90W |
| Heating Method | Heating Coil |
| Storage Container Temperature | Max. 40°C |
| Temperature | Max. 40°C |
| Water Temperature: | Avg. 33 ~ 35°C |
| 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 | 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 | 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 | Same |

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Table 2 Safety factor &amp; 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°C Water Temperature: Avg. 33 ~ 35°C Temperature Sensor: Bi-metallic Thermostats | No | Heating Method: Heating Coil Storage Container Temperature: Max. 40°C Water Temperature: Avg. 33 ~ 35°C 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/cm²) | Same | |
| Pressure of Air Supply | ≥550kPa | ≥550 kPa | 500kPa (Min) / 750kPa (Max) | Same | |
| Dental Chair | Loading Capacity | 150kg | 150kg | Max. 150 kg | |
| | 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 $&gt;400\mathrm{mL / min}$ for the subject device, while it is $&gt;750\mathrm{mL / min}$ 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 &amp; 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.

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