Disposable high speed air turbine handpiece is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

Device Description

The disposable high-speed air turbine handpiece is an air-driven dental handpiece for the use by a trained professional in the field of general dentistry. The device is an ergonomically shaped air-powered handpiece that is disposable. The device features a 4-pin (drive air, exhaust air, spray air and spray water holes) connector for air and water input and return. A water/air mist cools the head and bur. Dental burs (not part of this 510(k)) according to ISO 1797-1 type 3 could be inserted into the chuck system of the turbine.

The disposable high-speed air turbine dental handpiece is an instrument widely applied in oral therapy. It is composed of interrelated parts, working as a complete set. The disposable high-speed air turbine dental handpiece is an air-driven handpiece which supplied with water and air through the pipe and the coupling of a dental treatment unit. The device contains air and water pipes inside which supply air for driving the turbine assembly rotating and cooling water for work site as well as supply air and water for creating spray. The air-driven turbine assembly provides rotation to the bur for removing carious material, excess filling material, cavity, and is used for crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

The handpiece is supplied non-sterile and must be cleaned and sterilized before use.

AI/ML Overview

The provided document is an FDA 510(k) Substantial Equivalence Determination for a medical device (Disposable High Speed Air Turbine Handpiece). It details the device's characteristics, intended use, and comparison to a predicate device, along with the non-clinical testing performed to establish substantial equivalence.

However, the document does not describe a study involving an AI/machine learning device. Specifically, it is for a physical dental handpiece, and the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to compliance with engineering standards and performance benchmarks for a mechanical device, not an AI algorithm.

Therefore, I cannot provide the detailed information requested in your prompt (such as sample size for test/training sets, data provenance, number of experts, MRMC studies, standalone performance, etc.) because these concepts are applicable to AI/ML device studies, not the type of device and study described in this 510(k) summary.

The document confirms that this is a traditional 510(k) submission for a physical dental handpiece and explicitly states: "No clinical studies were performed."

If you were expecting information related to an AI/ML device, this document is not the correct source. It focuses on the substantial equivalence of a physical dental instrument based on its design, materials, and performance against established engineering standards (ISO 14457, ISO 9168, ISO 10993-1, etc.).

Summary

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August 11, 2020

Ningbo HPDOVE Dental Instruments Co., Ltd. % Charlie Mack Principal Engineer IRC 2950 E Lindrick Drive Chandler, AZ 85249

Re: K193264

Trade/Device Name: Disposable High Speed Air Turbine Handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class II Product Code: EFB Dated: May 20, 2020 Received: May 27, 2020

Dear Charlie Mack:

We have reviewed vour 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

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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 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 (QS) 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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,

for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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)

K193264

Device Name

Disposable High Speed Air Turbine 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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K193264

Image /page/3/Picture/1 description: The image shows a logo with a stylized bird-like figure inside a globe. The globe is represented by a grid of lines, and the bird-like figure is dark and appears to be made of a single, continuous line. The logo is simple and abstract, with the bird-like figure being the focal point.

NINGBO HPDOVE DENTAL INSTRUMENTS CO. LTD.

510(k) Summary (21 CFR §807.92)

Submitter Information:

Submitter Name:	NINGBO HPDOVE DENTAL INSTRUMENTS CO. LTD.
Address:	588 Xiaolin Road, Xiaolin Town, Cixi City, ZhejiangProvince, P.R.C. 315321
Telephone:	+86-574-63883911
Fax:	+86-574-63519378
Contact Person:	Mr. Liyue HuangManager
Email:	charliemack@irc-us.com
Date of Preparation:	July 20, 2020

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Subject Devices :

Trade/proprietary name: Disposable high-speed air turbine handpiece Model YCX-TOD-PP Common Name: Disposable high-speed air turbine handpiece Classification : 21CFR872.4200

Predicate Device:

Trade Name:	High-Speed Handpieces and Accessories
510(k) Reference:	K152146
Common Name:	Handpiece, air-powered, dental
Regulation Number:	21CFR872.4200
Regulatory Class:	Class II
Manufacturer:	Codent Technical Industry Co. Ltd.

Purpose of Submission

This is a new traditional 510(K) submission of Disposable high-speed air turbine handpiece.

Device Description

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the bur for removing carious material, excess filling material, cavity, and is used for crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

The handpiece is supplied non-sterile and must be cleaned and sterilized before use.

Indication for use

Disposable high-speed air turbine handpiece is intended for removing carious material, excess filling material, cavity, and crown preparation finishing tooth preparations and restorations, root canal preparations and polishing teeth.

Comparison with the predicate device:

Ningbo HPDOVE Dental Instruments Co. Ltd. believes that the Disposable high-speed air turbine handpiece is substantially equivalent to the Codent Technical Industry Co. Ltd. High-speed Handpieces and Accessories (K152146).

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The differences noted between the submitted Disposable high-speed air turbine handpiece and the predicate High-Speed Handpieces and Accessories are based on the use. The Disposable High Speed Air Turbine Handpiece, YCX-TOD-PP has the same use as the predicate and used in the same manner. Both the predicate and the submitted Ningbo HPDOVE Dental Instruments Co. Ltd Disposable High-Speed Air Turbine Handpiece, YCX-TOD-PP come non-sterile and must be sterilized before use. Please refer to the following pages for specific difference details.

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Comparison to Predicate Devices

Characteristics	Subject Device	Predicate Device
Name and model	Disposable high-speed air turbinehandpiece	High-speed Handpieces and Accessories
Model	YCX-TOD-PP	A4M4
510K Applicant	NINGBO HPDOVE DENTALINSTRUMENTS CO., LTD.	Codent Technical Industry Co., Ltd.
510(K) Number	Pending	K152146
RegulationNumber	CFR872.4200	CFR872.4200
Product Code	EFB	EFB
ClassificationName	Air-powered dental handpiece	Air-powered dental handpiece
OTC orPrescription	Prescription Use	Prescription Use
Medical Specialty	Dental	Dental
Indication for Use	Disposable high-speed air turbinehandpiece is intended for removingcarious material, excess filling material,cavity, and crown preparation, finishingtooth preparations and restorations, rootcanal preparations, and polishing teeth.	High-speed Handpieces and Accessoriesare intended for removing cariousmaterial, excess filling material, cavity,and crown preparation, finishing toothpreparations and restorations, root canalpreparations and polishing teeth.
Disposable	Disposable	Re-useable
Principles ofOperation	It is a handheld device that connects toa standard turbine connection on adental operative unit and delivers amixture of water and air to a treatmentsite.	It is a handheld device that connects to astandard turbine connection on a dentaloperative unit and delivers a mixture ofwater and air to a treatment site.
Operational Mode	Air-powered	Air-powered
Head Type	Standard	Standard
Angle of Shaft	90°	90°
Speed Range inrpms	300,000 rpm to 360,000 rpm	360,000 rpm
Drive Air Pressure	200 kPa - 245 kPa	245 kPa- 275 kPa
	2.09 kg/cm² - 2.5 kg/cm²	2.5 kg/cm²- 2.8 kg/cm²
Water Spray	Single	Single

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Characteristics	Subject Device	Predicate Device
Dental Bur Size	ISO 1797-1 Type3 / Ø1.59~1.60mm	ISO 1797-1 Type3 / Ø1.59~1.60mm
Dimensions(mm)	Length: 142~145Width: 20.5	Length: 84~~117Width: 19~~21
How Supplied	Non-sterile; Subject is sterilized Prior to use.	Non-sterile; Subject is sterilized before each use
Cleaning	Wipe the surface of the device with aclean, soft brush or cotton ball with 75%alcohol	Use the cleaning wire to clean the waterspray hole.
ApplicableSterilization	Moist heat - Autoclave sterilization	Moist heat - Autoclave sterilization
MaterialComposition	Brass, PES, silicon rubber	Stainless steel, Brass, Aluminum,Titanium
Coupling Pin	4-pin(drive air, exhaust air, spray air andspray water holes)	4-pin(drive air, exhaust air, spray air andspray water holes)
Fiber Optics	Without light	Without light
Accessories	Without coupling	Without coupling
Chunk Design	Chuck Tool	Push Button
Bur ExtractionForce	22-45 N	22-45 N
Lubrication	Lubricant is not required	Lubricant is required (Codent spraynozzle)
Performance	Complies with ISO 14457Complies with ISO 9168	Complies with ISO 14457Complies with ISO 9168
Biocompatibility	Complies with ISO10993-1 & ISO 7405	Complies with ISO10993-1 & ISO 7405

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Safety and Performance Data :

To establish substantial equivalence to the identified predicate devices, tests were completed as defined below to the subject devices, Disposable high-speed air turbine handpiece. The results of the testing demonstrate that the device complies with the applicable standards requirements, and the device is substantially equivalent to the predicate device.

Non-Clinical Study:

Performance:

ISO 14457 First edition 2012-09-15 Dentistry Handpieces and motors -
ISO 9168 Third edition 2009-07-15 Dentistry Hose connectors for air-driven dental handpieces

Biocompatibility:

ISO10993-1:2009/AC2010 -
ISO 10993-5: 2009 -
-ISO 10993-10: 2010

Sterility:

AAMI/ANSI/ISO 17665-1:2006. Sterilization of health care products -- Moist heat --- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices (Sterility)
-AAMI/ANSI/ISO 11737-1:2018, Sterilization of health care products --Microbiological methods -- Part 1: Determination of a population of microorganisms on products.
AAMI/ANSI/ISO 11138-1:2017, Sterilization of health care products -- Biological indicators -- Part 1: General requirements
-ANSI AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities
-AAMI/ANSI/ISO 14161: 2009, Sterilization of health care products — Biological indicators - Guidance for the selection, use and interpretation of results

Clinical Study:

No clinical studies were performed. l

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Package and Shelf Life:

The Disposable high-speed air turbine handpiece (YCX-TOD-PP ) is not subject to shelf life, as the device does not contain any sterile or degradable elements.

Conclusion:

The differences between the subject device and predicate device do not raise issues of safety and effectiveness based on the indication for use, technological characteristics, and performance testing. The subject device complies with the same applicable standards as the predicate device.

In accordance with the Federal Food, Druq and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, the subject device. Disposable high-speed air turbine handpiece, model YCX-TOD-PP is safe and effective and substantially equivalent to predicate devices as described herein.

END

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.