Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.

Device Description

The Dental Implant Unit is intended for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue. The device is composed of main unit, motor with tube, handpiece, foot pedal and holder. Eight different programs can be selected by the user. Switching between these programs is performed by foot control or via touch display. The programs include Positioning, Hole-drilling, Hole-Broadening, Tapping, Implanting, Lock the Abutment Screw, User Defined Mode and Cleaning. The control unit is intended to be used with the motor.

AI/ML Overview

The provided FDA 510(k) clearance letter and associated summary pertain to a Dental Implant Unit, which is a Class I medical device (a "Dental Handpiece and Accessories"). Class I devices are generally subject to general controls and are considered low-risk.

The documentation does not detail performance testing results for the device against specific, quantitative acceptance criteria for a clinical or software-based performance study as would be expected for a higher-risk Class II or Class III device, particularly those involving AI or diagnostic capabilities.

Instead, the submission focuses on demonstrating substantial equivalence ("SE") to a predicate device (K231845, also a dental implant unit) primarily through:

Engineering and design comparisons: Showing similar indications for use, fundamental operating principles, and safety features.
Compliance with recognized electrical safety and biocompatibility standards: This is the primary form of "performance testing" described.

Therefore, the following information will reflect what is discernible from the provided document, highlighting the absence of typical AI/diagnostic device study elements.

Acceptance Criteria and Device Performance (Based on Provided Document)

Acceptance Criteria Category	Specific Criteria (Derived from standards compliance or SE assertion)	Reported Device Performance (Summary from document)
Electrical Safety	Compliance with IEC 60601-1	Compliance Met: Passed IEC 60601-1 test.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2	Compliance Met: Passed IEC 60601-1-2 test.
Software Validation	Compliance with IEC 62304	Compliance Met: Software Validation performed.
Biocompatibility	Compliance with ISO 10993-1	Compliance Met: Biocompatibility testing performed compliant with ISO 10993-1.
Functionality	Device functions as intended (e.g., provides coolant, motor control, programming). Includes usability compliance.	Compliance Met: Function test performed; usability compliance ensured; enhanced power and lower start speed do not affect safety/effectiveness.
Sterilization & Shelf Life	Device can be sterilized, and maintains integrity over shelf life.	Compliance Met: Sterilization and Shelf Life & Packaging Test performed.

Study Information (Where applicable, based on provided text)

1. Sample sized used for the test set and the data provenance:
* Test Set Sample Size: Not specified in terms of patient data or typical "test set" for AI/diagnostic algorithms. The "test set" here refers to the device units themselves undergoing engineering and safety tests. The specific number of units tested is not provided, but implies typical engineering validation.
* Data Provenance: Not applicable in the context of patient data. The tests are laboratory/benchtop tests conducted to verify compliance with engineering standards.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* This is not applicable as the "ground truth" for a dental implant unit (a mechanical drive) is established by engineering specifications, calibration, and standardized testing procedures, not by expert human interpretation of medical images or clinical data. Experts involved would be engineers or technicians with relevant expertise in electrical safety, mechanical testing, and quality assurance.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable for this type of device and testing. Engineering tests rely on quantitative measurements against defined thresholds—there's no "adjudication" in the sense of resolving conflicting human interpretations.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
* No MRMC study was done. This device is a mechanical drive unit for dental surgery, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there is no "human reader" component or effect size to report.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This device is not an algorithm or AI system. It is a piece of hardware. While it has software ("Compliance with IEC 62304"), this software controls the mechanical functions of the unit (e.g., motor speed, irrigation), not performs diagnostic or interpretive tasks.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Engineering Specifications and International Standards: The "ground truth" for this device's performance is compliance with established international standards for electrical safety (IEC 60601-1, IEC 60601-1-2), software (IEC 62304), and biocompatibility (ISO 10993-1), as well as verification against its own design specifications (e.g., speed range, output power). There is no "pathology" or "outcomes data" ground truth in this context.

7. The sample size for the training set:
* Not applicable. This is a hardware device; it does not have a "training set" in the machine learning sense. The software it contains likely undergoes traditional software development and validation, but not machine learning training.

8. How the ground truth for the training set was established:
* Not applicable. See point 7.

Summary

FDA 510(k) Clearance Letter - Dental Implant Unit

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

Doc ID # 04017.07.05

April 11, 2025

Guilin AestheDent Medical Instruments Co., Ltd
℅ Salon Chen
System Engineer
IMD Medical & Drug technology service institutions
Room 308, Building 11, No. 23 Jinqu Road, Wanjiang District
Dongguan, 523039
CHINA

Re: K242646
Trade/Device Name: Dental Implant Unit
Regulation Number: 21 CFR 872.4200
Regulation Name: Dental Handpiece And Accessories
Regulatory Class: Class I, reserved
Product Code: EBW,
Dated: March 17, 2025
Received: March 17, 2025

Dear Salon Chen:

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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K242646 - Salon Chen 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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K242646 - Salon Chen 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

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Indications for Use

Submission Number (if known)
K242646

Device Name
Dental Implant Unit

Indications for Use (Describe)

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
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"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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K242646

510(k) Summary

1. 510(k) Sponsor:

Company Name: Guilin AestheDent Medical Instruments Co., Ltd.
Address: 3rd Floor, Building 12th, Guilin Creative Industry Park, No. 70, Qilidian Road, Qixing District, Guilin City, Guangxi Province, 541004, P.R. China
Phone: +86 13977319343
Contact Person (Title): Wen Guofeng (General Manager)
E-mail: 12073376@qq.com
Date of Preparation: March 17, 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: Dental Implant Unit
Model: IMPLANT surg

4. Common Name and Classification:

Device Classification Name: Dental Handpiece and Accessories

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Classification Product Code: EBW
Regulation Number: 872.4200
Class: Class I
Review Panel: Dental

5. Predicate Device Information:

510(k) Number: K231845
Device Classification Name: Dental Handpiece and Accessories
Sponsor: Guilin Woodpecker Medical Instrument Co., Ltd.
Classification Product Code: EBW
Regulation Number: 872.4200
Class: Class I
Review Panel: Dental
Trade/Proprietary Name: Implanter incl. Accessories

6. Device Description

7. Indications for Use

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8. Comparison to the predicate device

8.1. Table 1 General Comparison

Elements of Comparison	Proposed Device	Predicate Device	Judgment
Company Name	Guilin AestheDent Medical Instruments Co., Ltd.	Guilin Woodpecker Medical Instrument Co., Ltd.	/
Device Name	Dental Implant Unit	Implanter incl. Accessories	/
Regulation Description	Dental Handpiece And Accessories	Dental Handpiece And Accessories	SE
Review Panel	Dental	Dental	SE
Classification Product Code	EBW	EBW	SE
Regulation Number	872.4200	872.4200	SE
Class	Class I	Class I	SE
Prescription or OTC	Prescription Use	Prescription Use	SE
Environment of Use	Dental practice/ Dental clinic	Dental practice/ Dental clinic	SE

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| Intended Use | Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue. | Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue. | SE |

8.2. Table 2 Safety factor & Performance Comparison

Safety factor & Performance	Proposed Device	Predicate Device	Judgment
Electrical Safety	Compliance with IEC 60601-1	Compliance with IEC 60601-1	SE
EMC	Compliance with IEC 60601-1-2	Compliance with IEC 60601-1-2	SE
Software	Compliance with IEC 62304	Compliance with IEC 62304	SE
Biocompatibility	Compliance with ISO 10993-1	Compliance with ISO 10993-1	SE
Control Unit	Main dimensions: 286mm × 252mm × 113mmFront panel: Display with capacitive touchPrograms: 8 programs for various stages of implantologyIrrigation: 110ml/min.Irrigation Tubing can be inserted ergonomically on the unit's side face	Main dimensions: 276mm x 267mm x 110 mmFront panel: Display with capacitive touchPrograms: 8 programs for various stages of implantologyIrrigation: 110ml/min.Irrigation Tubing can be inserted ergonomically on the unit's side face	Different, Note1

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Safety factor & Performance	Proposed Device	Predicate Device	Judgment
Foot control	Main dimension: 236mm x 168mm x 65mmFeatures: 4 buttons for pump on/off Forward/reverse Change programs Motor control (on/off and variable)Power supply: wired via cable	Main dimension: 249.7mm x 181.7mm x 160.8mmFeatures: 4 buttons for pump on/off Forward/reverse Change programs Motor control (on/off and variable)Power supply: wired via cable	Different, Note1
Motor with cable	Length: 108 mmWith LED contacts	Length: 110 mmWith LED contacts without LED contacts	Different, Note 1
Max. Mechanical output power	150W	120W	Different, Note 2
Torque at the motor	5.5 Ncm	5.5 Ncm	SE
Speed range of motor	200 - 40,000 rpm	300 - 40,000 rpm	Different, Note 3
Supply voltage	100-240VAC	100-120VAC	SE
Rated current	1.5-2A	1.5-2A	SE
Frequency	50-60HZ	50-60Hz	SE
Lubrication	After max. 30 minutes of UseMotor: No lubrication is needed	After max. 30 minutes of useSPM58L: No lubrication is needed	SE

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Safety factor & Performance	Proposed Device	Predicate Device	Judgment
Cleaning, Disinfection & Sterilization	Required	Required	SE

8.3. Review of Differences:

Note 1 Dimensions Difference

The proposed device has slightly different dimensions on control unit, foot control, and motor cable length compared to the predicate device. Despite this, the usability compliance ensures that the subject device is safe and effective for its intended use. Furthermore, 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 2 Dimensions Difference

The proposed device has a higher maximum mechanical output power (150 W) compared to the predicate device (120 W). This increase in power provides greater flexibility and efficiency during dental procedures, particularly when dealing with harder tissues or when more torque is required. Despite this, the proposed device has passed series of electrical safety and usability tests which demonstrates the enhanced power capacity simply offers improved performance without altering the device's fundamental operation or intended use. Therefore, this difference does not affect the safety and effectiveness of the proposed device compared to the predicate device.

Note 3 Motor speed range difference

The proposed device operates at a speed range of 200 - 40,000 rpm, whereas the

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predicate device operates at 300 - 40,000 rpm. The lower starting speed allows for more precise control during delicate procedures, such as initial drilling or preparation stages where lower speeds are advantageous. The upper speed limit remains the same (40,000 rpm) for both devices, ensuring that the proposed device maintains the same high-speed capabilities as the predicate. The expanded speed range enhances the versatility of the device without compromising safety or effectiveness. Therefore, this difference does not affect the safety and effectiveness of the proposed device compared to the predicate device.

9. Discussion of Non-clinical Tests Performed for Determination of Substantial Equivalence are as follows:

The proposed device is the same as the predicate device but the two devices are different. A series of safety and performance tests were conducted on the subject device:

Sterilization and Shelf Life & Packaging Test
Biocompatibility
Software Validation
Electromagnetic Compatibility and electrical safety
Function test

All the test results demonstrate the proposed device meets the requirements of its pre-defined acceptance criteria and intended uses, and is substantially equivalent to the predicate device.

10. Conclusion

Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.