(270 days)
Not Found
No.
The document describes a dental unit with electronic controls and software for chair movements and water/air functions, but it does not mention any AI, machine learning, or deep neural network components. The device is a mechanical and electronic system for dental procedures.
No
Explanation: The device is described as a base and power supply for dental devices, providing an environment for dental procedures rather than directly administering therapy itself. It supports therapeutic devices (like handpieces), but is not inherently therapeutic.
Yes
Explanation: The "Intended Use / Indications for Use" section states, "Integral Dental Unit is intended to be used in a professional environment for dental diagnosis, treatment, or operation." This explicitly includes diagnosis as an intended use.
No
The device is a physical dental unit with a chair, lights, and connections for other dental instruments. While it mentions "software and water/air unit functions" and "electronically-controlled chair movements with software," the primary function and components are hardware-based. The software appears to control the hardware components and their movements rather than acting as a standalone medical device. The 510(k) summary clearly describes numerous physical components and their specifications (e.g., power supply, chair loading capacity, noise levels), affirming it is a physical medical device incorporating software, not a software-only medical device.
No
The device is a dental unit intended for diagnosis, treatment, or operation within a dental clinic environment. It does not perform tests on biological samples or provide information for diagnostic purposes based on in vitro examination.
N/A
Intended Use / Indications for Use
The Integral Dental Unit 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.
Product codes (comma separated list FDA assigned to the subject device)
EIA, KLC
Device Description
The Integral Dental Unit (Model: YD-A4) is a dental operative unit specially designed and provided for a qualified dentist to be used in a professional clinic or hospital facility to carry out dental procedures.
Integral Dental Unit is intended to be used in a professional environment for dental diagnosis, treatment, or operation.
It includes a treatment chair, dentist element, assistant element and a dental light as offering several additional options and electronically-controlled chair movements with software and water/air unit functions.
The dental unit consists of an electronically operated dental chair and integrated control unit control for electricity, water and air supply to handpieces or some other dental instrument. The device is equipped with an instrument tray, pipes for water supply and tube air supply, a mouth lamp, a saliva aspirator, a spittoon, a three-way syringe, a film viewer, a foot switch and chair with driving motors and armrest.
The dental chair is intended to be used with dental hand pieces, cure light, ultrasonic scaler, camera system or other doctor stool, which is not provided by the manufacturer. The user will select the dental instruments and accessories with FDA clearance by themself. So, the device in the submission does not include these parts and accessories. The connector standard type complies with ISO 9168.
Basic parameters/use conditions/power supply specifications is as follows:
◆Noise ＜70 dBA
◆Base box Power supply: 115/230 Vac, 50/60Hz, single-phase 3core, protective grounding.
Power input: 380 VA
Water filter hole diameter: 15 kPa;
- water pumping rate＞80 mL/min
Strong saliva:
- vacuum degree >25 kPa;
- water pumping rate＞1000 mL/min
◆Instrument tray Rotating angle: >270º
Up-down moving range: >440mm
Max. Load: 85 Ra
◆Foot switch Tripping force: >10N and 25 000 repeats
◆Dental chair Power supply: 24 V dc Inside power supply
Loading capacity: 1323N (about 135 Kg)
Loading capacity of headrest: 300N (about 30Kg)
Moving range of headrest: 120mm
Range of backrest when going backwards: 90º~170º
Seat cushion's maximum height away from ground: 730mm
Seat cushion's minimum height away from ground: 450mm
Attachment
----- Amalgam separation device
It has a medical device product registration card
Attachment parameters are reflected in its operating instructions
◆Work space L: ≥3 000 mm; W: ≥2 000 mm; H: ≥2 500 mm
◆Environment for operation
Temperature: +5°C to +40°C
Relative humidity: 30% - 80%
Atmospheric pressure: 86kPa ~ 106kPa
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 dental professionals, dentists and/or dental assistants.
dental clinic 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)
The Integral Dental Unit was evaluated for conformance to recognized international standards. The following is a list of these evaluations and tests that were found to be in conformance:
-
Electrical safety test
IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
IEC 80601-2-60:2019, Medical electrical equipment Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment -
Electromagnetic compatibility test
IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -
Biocompatibility test
ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process -
Software verification and validation test
FDA "Guidance for Premarket Submissions and for Software Contained in Medical Devices" -
Software Life Cycle Processes
IEC 62304:2006+AMD1:2015 Medical Device Software -
Performance Testing
ISO 7494-1:2018, Dentistry – Stationary dental units and dental patient chairs, Part 1: General requirements
ISO 7494-2:2018, Dentistry – Stationary dental units and dental patient chairs, Part 2: Air, water, suction and wastewater systems
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
FDA 510(k) Clearance Letter - Integral Dental Unit
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 27, 2025
Guangdong Yadeng Medical Apparatus Co., Ltd.,
℅ Jett Lee
Official Applicant
Guangdong Jianda Medical Technology Co., Ltd.
906 Room
Longxiang Garden, Tianhe district
GuangZhou, Guangdong 510000
CHINA
Re: K243130
Trade/Device Name: Integral Dental Unit
Regulation Number: 21 CFR 872.6640
Regulation Name: Dental Operative Unit And Accessories
Regulatory Class: Class I, reserved
Product Code: EIA, KLC
Dated: May 26, 2025
Received: May 27, 2025
Dear Jett Lee:
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.
Page 2
K243130 - Jett Lee 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-
Page 3
K243130 - Jett Lee 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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K243130
Device Name
Integral Dental Unit
Indications for Use (Describe)
The Integral Dental Unit 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.
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."
Page 5
June 23, 2025
K243130 - 510(k) Summary
1. Submitter's Information
Sponsor
- Company Name: GUANGDONG YADENG MEDICAL APPARATUS CO., LTD.
- Address: Factory 2, No.12, Fenggong Road, Nansha Industrial Zone, Danzao Town, Nanhai District, Foshan, Guangdong, 528216, P.R. China
- Phone: +86- 15916558838
- Fax: +86-0757-86603813
- Contact Person (including title): Weng changming
- E-mail: 541405168@qq.com
Application Correspondent
- Company: Guangdong Jianda Medical Technology Co., Ltd
- Address: 906 Room, Longxiang Garden, Tianhe district, Guangzhou, China
- Contact Person: Jett Lee
- Tel: 86-13512755282
- Email: jianda-lee@foxmail.com
2. Subject Device Information
- Type of 510(k) submission: Traditional
- Common Name: Unit, Operative Dental
- Trade Name: Integral Dental Unit
- Model: YD-A4
- Classification Name: Dental Operative Unit and Accessories
- Review Panel: Dental
- Product Code: EIA
- Regulation Number: 872.6640
- Regulation Class: I
3. Predicate Device Information
| Predicate Device | |
|---|---|
| Sponsor | Osstem Implant Co., Ltd. |
| Device Name | K3 |
| Model | / |
| 510(k) Number | K183347 |
Page 6
| Product Code | EIA |
|---|---|
| Regulation Number | 872.6640 |
| Regulation Class | I |
4. Device Description
The Integral Dental Unit (Model: YD-A4) is a dental operative unit specially designed and provided for a qualified dentist to be used in a professional clinic or hospital facility to carry out dental procedures.
Integral Dental Unit is intended to be used in a professional environment for dental diagnosis, treatment, or operation.
It includes a treatment chair, dentist element, assistant element and a dental light as offering several additional options and electronically-controlled chair movements with software and water/air unit functions.
The dental unit consists of an electronically operated dental chair and integrated control unit control for electricity, water and air supply to handpieces or some other dental instrument. The device is equipped with an instrument tray, pipes for water supply and tube air supply, a mouth lamp, a saliva aspirator, a spittoon, a three-way syringe, a film viewer, a foot switch and chair with driving motors and armrest.
The dental chair is intended to be used with dental hand pieces, cure light, ultrasonic scaler, camera system or other doctor stool, which is not provided by the manufacturer. The user will select the dental instruments and accessories with FDA clearance by themself. So, the device in the submission does not include these parts and accessories. The connector standard type complies with ISO 9168.
Basic parameters/use conditions/power supply specifications is as follows:
◆Noise ＜70 dBA
◆Base box Power supply: 115/230 Vac, 50/60Hz, single-phase 3core, protective grounding.
Power input: 380 VA
Water filter hole diameter: 15 kPa;
- water pumping rate＞80 mL/min
Strong saliva:
- vacuum degree >25 kPa;
- water pumping rate＞1000 mL/min
◆Instrument tray Rotating angle: >270º
Up-down moving range: >440mm
Max. Load: 85 Ra
◆Foot switch Tripping force: >10N and 25 000 repeats
◆Dental chair Power supply: 24 V dc Inside power supply
Loading capacity: 1323N (about 135 Kg)
Loading capacity of headrest: 300N (about 30Kg)
Moving range of headrest: 120mm
Range of backrest when going backwards: 90º~170º
Seat cushion's maximum height away from ground: 730mm
Seat cushion's minimum height away from ground: 450mm
Attachment
----- Amalgam separation device
It has a medical device product registration card
Attachment parameters are reflected in its operating instructions
◆Work space L: ≥3 000 mm; W: ≥2 000 mm; H: ≥2 500 mm
◆Environment for operation
Temperature: +5°C to +40°C
Relative humidity: 30% - 80%
Atmospheric pressure: 86kPa ~ 106kPa
5. Intended Use / Indications for Use
The Integral Dental Unit 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.
6. Test Summary
The Integral Dental Unit was evaluated for conformance to recognized international standards. The following is a list of these evaluations and tests that were found to be in conformance:
Page 8
-
Electrical safety test
IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
IEC 80601-2-60:2019, Medical electrical equipment Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment -
Electromagnetic compatibility test
IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -
Biocompatibility test
ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process -
Software verification and validation test
FDA "Guidance for Premarket Submissions and for Software Contained in Medical Devices" -
Software Life Cycle Processes
IEC 62304:2006+AMD1:2015 Medical Device Software -
Performance Testing
ISO 7494-1:2018, Dentistry – Stationary dental units and dental patient chairs, Part 1: General requirements
ISO 7494-2:2018, Dentistry – Stationary dental units and dental patient chairs, Part 2: Air, water, suction and wastewater systems
7. Comparison to predicate device and conclusion
The subject device Integral Dental Unit is substantially equivalent to the predicated device based on intended use, design, specifications and performance. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
Information for predicate device was obtained from publicly available sources. A technical comparison to the predicate is provided below.
| Elements of Comparison | Subject Device | Predicate Device I | Verdict |
|---|---|---|---|
| 510(k) Number | K243130 | K183347 | -- |
| Device Name | Integral Dental Unit (Model: YD-A4) | K3 | -- |
| Product Code | EIA | EIA | Same |
| Regulation Number | 21 CFR 872.6640 | 21 CFR 872.6640 | Same |
| Regulation Class | I | I | Same |
| Prescription | Prescription use | Prescription use | Same |
Page 9
| Intended Use | The Integral Dental Unit 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. | K3 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 |
|---|---|---|---|
| Power & Utility Supply | AC 230V, 50/60Hz, compressed air and water | AC 100-120/220-240V, 50/60Hz, compressed air and water | Similar Note 1 |
| Main Components | Ground box, foot controller, patient chair, weak suction system, strong suction system, Triple function handpiece(hot), cuspidor: water flues& supply, cabinet box, operation lamp, film viewer, instrument control system, instrument tray, Triple function handpiece(cold), cup collector, glass plate | Chair, Unit, Table, Seat, Stool, Monitor Arm*, Hanaro Console* (Note: K3 Cart* model applied ONLY) | Similar Note 1 |
| Syringe | 3-way syringe | 3-way syringe | Same |
| Control of water and air | Uses pneumatically controlled vales to water control the flow of air and water. On/off and intensity controlled by foot pedal. | Uses pneumatically controlled vales to water control the flow of air and water. On/off and intensity controlled by foot pedal. | Same |
| Air Pressure | 0.6MPa～0.80 MPa | 500kPa(min)/750kPa(max) | Similar Note 1 |
| Water Pressure | 0.20 MPa ～0.40 MPa | 250kPa(min)/600 kPa(max) | Similar Note 1 |
| Water System | City water supply | City water supply | Same |
| Patient Load | Max. 135kg | Max. 135kg | Same |
| Chair Height | Max. 730±10mm, Min. 450±10mm | Max. 795±10mm, Min. 365±10mm | Similar Note 1 |
| Lift Motor | Hydraulic electromotor | Hydraulic electromotor | Same |
| Electrical Safety | Complied with IEC 60601-1 | Complied with IEC 60601-1 | Same |
| Electromagnetic compatibility | Complied with IEC 60601-1-2 | Complied with IEC 60601-1-2 | Same |
Summary for clinical test
Clinical performance testing was not performed for this device.
Conclusion
Based on the above performance as documented in this application, Integral Dental Unit is substantially equivalent to the predicate device, K3 (K183347). Thus, the subject device is substantially equivalent to the predicate devices.