This Highspeed Airturbine Handpiece is intended for removal of carious material, cavities and crow preparations, removal of filings, processing of tooth, restoration of surfaces and as a surgical tool for third molar removal procedures It is designed for use by a trained professional in the field of general dentistry.

Device Description

The Highspeed Airturbine Handpiece is air driven dental handpieces for the use by a trained professional in the field of general dentistry. The devices are air-powered handpieces that are reusable and ergonomically shaped. The devices can be sterilized by the pre-vacuum Autoclave methods. Through the coupling connected to a dental unit, the proposed dental handpiece receive air for functionality of the high speed turbine.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for the device's performance in the typical sense of a diagnostic or predictive algorithm. Instead, it focuses on compliance with established international standards for dental devices and comparison to predicate devices, demonstrating substantial equivalence. The "performance" section for the proposed device cites compliance with these standards.

Acceptance Criteria (Standard Compliance)	Reported Device Performance
ISO 10993-5:2009 (Cytotoxicity)	Biocompatibility demonstrated (via K172543)
ISO 10993-10:2010 (Irritation & Sensitization)	Demonstrated by K172543 (No Intracutaneous Reactivity, No Skin Sensitization)
ISO 9168:2009 (Hose Connectors)	Compliance with ISO 9168:2009
ISO 14457:2012 (Handpieces & Motors)	Compliance with ISO 14457:2012
ASTM D4169:2016 (Shipping Containers)	Complies with standard
FDA Reprocessing Guidance Document (Cleaning & Sterilization)	Cleaning and Sterilization Validation per guidance
Light Intensity (Requirement of ISO 14457)	Meets requirement of ISO 14457 (though different from predicate)
Speed in RPMs (Performance Test per ISO 14457)	Test results meet acceptable criteria for ISO 14457
Bur Retention Force (from Comparison Table)	22~~45 N cm (compared to predicate's "Up to 24 N cm" and reference's ">22N/22~~45N") - considered "SE"
Sterilization (per ISO 17665)	Sterilization parameters comply with ISO 17665 standard

2. Sample size used for the test set and the data provenance

Not applicable. This is a submission for a physical medical device (dental handpiece), not a software or AI device that typically uses test sets or data. The "tests" mentioned are non-clinical studies evaluating physical and biological properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a physical device submission. Ground truth, in the context of expert consensus, is not a relevant concept here.

4. Adjudication method for the test set

Not applicable. This is a physical device submission.

5. 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

Not applicable. This is a physical device submission, not an AI or diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical device submission.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. For this physical device, "ground truth" would be the objective measurements and adherence to specified performance standards as evaluated in non-clinical laboratory settings.

8. The sample size for the training set

Not applicable. This is a physical device submission; there is no "training set" in the context of an algorithm.

9. How the ground truth for the training set was established

Not applicable. As above, there is no training set for this type of device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" proving the device meets acceptance criteria is a series of non-clinical tests conducted to demonstrate the proposed Highspeed Airturbine Handpiece's compliance with established international standards and its substantial equivalence to legally marketed predicate devices.

Non-Clinical Test Conclusion (Section 6): The submission states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."
Standards Complied With: The tests demonstrated compliance with:
- ISO 10993-5:2009 (Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity)
- ISO 10993-10:2010 (Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization)
- ISO 9168:2009 (Dentistry - Hose Connectors For Air Driven Dental Handpieces)
- ISO 14457:2012 (Dentistry - Handpieces And Motors)
- ASTM D4169:2016 (Standard Practice For Performance Testing Of Shipping Containers And Systems)
- FDA Reprocessing Guidance Document (Cleaning and Sterilization Validation)
Biocompatibility: For biocompatibility, the proposed device's patient-contact materials (brass and aluminum) were considered identical to those in reference device K172543. The document states that "The biocompatibility testing for K172543 was evaluated and the tests results complied with ISO 10993 standards." This essentially leverages prior testing on a similar, already cleared device from the same manufacturer.
Performance (Speed in RPMs): "the performance test has been conducted on proposed device according to ISO 14457 and the test results meet the acceptable criteria."
Sterilization: The sterilization parameters tested "comply with ISO 17665 standard."

Overall: The acceptance criteria are essentially defined by compliance with recognized international and national standards for dental handpieces, and "performance" is demonstrated through non-clinical testing against these standards, often referencing predicate devices for establishing substantial equivalence. No clinical studies were included in this submission (Section 7).

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 8, 2021

Beijing Dongbo Dental Handpiece Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O.Box 120-119 Shanghai, 200120 CHINA

Re: K202371

Trade/Device Name: Highspeed Airturbine Handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EFB Dated: August 5, 2021 Received: August 10, 2021

Dear Diana Hong:

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 (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 located 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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, M.ChE. 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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Indications for Use

510(k) Number (if known)

K202371

Device Name Highspeed Airturbine Handpiece

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)

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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K202371

1. Date of Preparation: November 7, 2021
1. Sponsor Identification

Beijing Dongbo Dental Handpiece Co., Ltd.

3F, Building 3, No. 17, First Jinmayuan Street, Shunyi District, Beijing, China

Establishment Registration Number: 3515005486

Contact Person: Chao Hao

Position: Administration office

Tel: +86-10-80479758

Fax: +86-10-80478329

Email: haochao123459@126.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person)

Ms. Huifan Wang (Alternative Contact Person)

Mid-Link Consulting Co., Ltd.

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850,

Fax: +1-360-925-3199

Email: info@mid-link.net

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1. Identification of Proposed Device
  Trade Name: Highspeed Airturbine Handpiece Common Name: Handpiece, Air-powered, Dental Regulatory Information Classification Name: Dental Handpiece and Accessories Classification: I; Product Code: EFB; Regulation Number: 21CFR 872.4200 Review Panel: Dental

Indication for Use:

It is designed for use by a trained professional in the field of general dentistry.

Device Description

ર. Identification of Predicate Device
Predicate device 510(k) Number: K141576 Product Name: Maxima PRO 45L Reference device 510(k) Number: K172543 Product Name: High-speed Turbine Handpieces for Single Use
1. Non-Clinical Test Conclusion
  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:

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ISO 10993-5: 2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
ISO 9168:2009 Dentistry - Hose Connectors For Air Driven Dental Handpieces
ISO 14457:2012 Dentistry - Handpieces And Motors
ASTM D4169:2016 Standard Practice For Performance Testing Of Shipping Containers And Systems
Guidance for Industry and FDA Staff- Dental Handpieces- Premarket Notification [510(k)] Submissions
Cleaning and Sterilization Validation per the FDA Reprocessing Guidance Document
1. Clinical Test Conclusion

No clinical study is included in this submission.

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8. Substantially Equivalent (SE) Comparison

ITEM	Proposed Device	Predicate Device	Reference Device	Remark
		K141576	K172543
Product Code	EFB	EFB	EFB	Same
Classification	Class I	Class I	Class I	Same
RegulationNumber	21 CFR 872.4200	21 CFR 872.4200	21 CFR 872.4200	Same
Indication foruse	This Highspeed AirturbineHandpiece is intended forremoval of cariousmaterial, cavities and crowpreparations, removal offilings, processing of tooth,restoration of surfaces andas a surgical tool for thirdmolar removal proceduresIt is designed for use by atrained professional in thefield of general dentistry.	This air-powered dentalhandpiece is intended forremoval of carious material,cavities and crowpreparations, removal offilings, processing of tooth,restoration of surfaces and asa surgical tool for third molarremoval proceduresIt is designed for use by atrained professional in thefield of general dentistry.	High-speed TurbineHandpieces for Single Useare intended for removingcarious material, excessfilling material, cavity andcrown preparation, finishingtooth preparations andrestorations, root canalpreparations and polishingteeth.	Same
Principle ofoperation	Air power	Air power	Air power	Same
Patient-contactmaterial	BrassAluminum	Round CopperCr-N/Cr CoatingRound SteelCr CoatingEcobrass	BrassAluminumABS	Different
Air/waterspray	water	water	Water	Same
Water cooling	Yes	Yes	Yes	Same
Fiber optics	With/without light	With light	Without light	Different
Type of chuck	Push Button	Push Button	Push Button	Same
Light intensity	More than 7000 LUX	Approx. 25,000 LUX	NA	Different
Typeofconnectors	Hose connection	Hose connection	Hose connection	Same
Speed in rpms	350,000; 380,000; 480,000rpm	380,000~420,000 rpm	350,000; 380,000rpm	Different
Bur retentionforce (N cm)	22~45	Up to 24	>22N/22~45N	SE
Headdiameter(mm)	12.5, 11, 9.5	12.5	Unknown	Different
OperatingPressure	245Kpa (~35.53psi)	40psi	245Kpa	Same
Head angle	18 and 45 degree	45 degree	18 and 45 degree	Same
Singleuse/Reuse	Reuse	Reuse	Single-use	Same
Sterilization	Autoclave sterilization	Gravity steam autoclave	Radiation	Different
Cytotoxicity	Biocompatibility	No Cytotoxicity	No Cytotoxicity	Different
IntracutaneousReactivity	demonstrated by K172543	No Intracutaneous Reactivity	No Intracutaneous Reactivity
SkinSensitization		No Skin Sensitization	No Skin Sensitization
Performance	Compliance with ISO14457:2012 and ISO9168:2009	Compliance with ISO14457:2012 and ISO9168:2009	Compliance with ISO14457:2012 and ISO9168:2009	Same

Table 1 Comparison of Technology Characteristics

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Different- Patient-contact material

The patient-contact materials of the proposed device are different from the predicate devices, but the brass and aluminum of the proposed device is the same as the brass and aluminum of reference device, which is also manufactured by Beijing Dongbo Dental Handpiece Co., Ltd. The biocompatibility test has been conducted on the K172543 and the test result comply with the requirements of ISO 10993. Therefore, the different will not affect the safety and effectiveness of the proposed device

Different- Fiber optics

The fiber optics of the proposed device are different from the predicate device or reference device. The proposed device contains handpieces with and without lighting function. However, the predicate device is handpieces with light and the reference device is handpieces without light. Therefore, the fiber optics (with/without light) will not affect the safety and effectiveness of the proposed device.

Different- Light intensity

The light intensity of the proposed device is different from the predicate device. However, the light intensity of the proposed device meet the requirement of ISO 14457. And the proposed device shall be operated by trained healthcare professions. Therefore, the different will not affect the safety and effectiveness of the proposed device. Therefore, the different will not affect the safety and effectiveness of the proposed device.

Different- Speed in rpms

The speeds of the proposed device are different from the predicate device. The 480,000rpm are out range of the predicate device. The different speeds will be selected by physician per patients' condition.

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In addition, the performance test has been conducted on proposed device according to ISO 14457 and the test results meet the acceptable criteria. Therefore, the different will not affect the safety and effectiveness of the proposed device.

Different- Head diameter

The head diameter of the proposed device is different from the predicate device. The 11mm and 9.5mm are out range of the predicate device. However, the difference is just in physical specification and different specification will be selected by physician per patients' condition. Therefore, the different will not affect the safety and effectiveness of the proposed device.

Different- Sterilization

The steam sterilization method of the proposed device are different with the predicate device. However, the sterilization parameters comply with ISO 17665 standard. Therefore, the difference will not affect the safety and effectiveness of the proposed device.

Different- Biocompatibility

The patient-contact materials of the Highspeed Airturbine Handpiece are identical device to that of the legally marketed device, High-speed Turbine Handpieces for Single Use, as cleared in K172543, which is also manufactured by Beijing Dongbo Dental Handpiece Co., Ltd. Therefore, the biocompatibility for proposed device is demonstrated by reference device (K172543). The biocompatibility testing for K172543 was evaluated and the tests results complied with ISO 10993 standards. Therefore, the patient-contact materials of the proposed device will not have the adverse effects on patients. Therefore, this difference does not affect the safety and effectiveness of the proposed device.

9. Substantially Equivalent (SE) Conclusion

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

Regulation Number and Section

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.