Highspeed Airturbine Handpiece

• K Number: K202371
• Device Name: Highspeed Airturbine Handpiece
• Manufacturer: Beijing Dongbo Dental Handpiece Co., Ltd.
• Date Cleared: 2021-11-08 ( 446 days)
• Product Code: EFB
• Regulation Number: 872.4200

Intended Use

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.

Predicate Devices

K141576

Reference Devices

K172543

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical and sterilization properties, with no mention of AI/ML or data processing.

Therapeutic

No.
A therapeutic device is one that treats a disease or condition. This device is used 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, which are procedures, not treatments.

Diagnostic

No

The device is a surgical tool used for material removal and surface processing in dentistry, not for diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly states it is an air-driven dental handpiece, which is a physical hardware device. It also mentions sterilization and connection to a dental unit, further indicating a hardware component.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
• Device Function: The description clearly states that this device is a "Highspeed Airturbine Handpiece" used for procedures directly on the tooth (removal of material, preparation, etc.). It is a surgical/dental tool used in vivo (within the living body), not for testing samples in vitro (in a lab setting).
• Intended Use: The intended use describes procedures performed directly on the patient's teeth, not laboratory testing of samples.

Therefore, based on the provided information, this device falls under the category of a dental surgical instrument, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

EFB

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Tooth / Oral Cavity

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Trained professional in the field of general dentistry.

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)

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:

• 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

No clinical study is included in this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K141576

Reference Device(s)

K172543

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

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 ([e-mail]) or phone [phone] 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)

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.

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
• 2. 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: [phone]

Fax: [phone]

Email: [e-mail]

• 3. 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: [phone],

Fax: [phone]

Email: [e-mail]

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• 4. 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:

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.

• 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

• 6. 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

• 7. 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
Regulation
Number	21 CFR 872.4200	21 CFR 872.4200	21 CFR 872.4200	Same
Indication for
use	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.	This air-powered dental
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.	High-speed Turbine
Handpieces for Single Use
are intended for removing
carious material, excess
filling material, cavity and
crown preparation, finishing
tooth preparations and
restorations, root canal
preparations and polishing
teeth.	Same
Principle of
operation	Air power	Air power	Air power	Same
Patient-contact
material	Brass
Aluminum	Round Copper
Cr-N/Cr Coating
Round Steel
Cr Coating
Ecobrass	Brass
Aluminum
ABS	Different
Air/water
spray	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
Type
of
connectors	Hose connection	Hose connection	Hose connection	Same
Speed in rpms	350,000; 380,000; 480,000
rpm	380,000~420,000 rpm	350,000; 380,000rpm	Different
Bur retention
force (N cm)	22~45	Up to 24	>22N/
22~45N	SE
Head
diameter(mm)	12.5, 11, 9.5	12.5	Unknown	Different
Operating
Pressure	245Kpa (~35.53psi)	40psi	245Kpa	Same
Head angle	18 and 45 degree	45 degree	18 and 45 degree	Same
Single
use/Reuse	Reuse	Reuse	Single-use	Same
Sterilization	Autoclave sterilization	Gravity steam autoclave	Radiation	Different
Cytotoxicity	Biocompatibility	No Cytotoxicity	No Cytotoxicity	Different
Intracutaneous
Reactivity	demonstrated by K172543	No Intracutaneous Reactivity	No Intracutaneous Reactivity
Skin
Sensitization		No Skin Sensitization	No Skin Sensitization
Performance	Compliance with ISO
14457:2012 and ISO
9168:2009	Compliance with ISO
14457:2012 and ISO
9168:2009	Compliance with ISO
14457:2012 and ISO
9168:2009	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.