Dental High-speed Turbine Handpiece is intended for removing carious material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

Device Description

The Dental High-speed Turbine Handpiece is the dental treatment for patients with tooth disease tools, which is an effective instrument for drilling, grinding, repairing. It composed of handpiece and a connector. The handle is slide-proof, comfortable and easy to clean. Handpiece and adaptors can bear steam disinfection at 135°C. The head angle can provide better operational vision and and efficiency can be improved. Cartidges have high precision when rotating, cartiridges have low noise and high efficiency. The scope of application: for dental professional use only. Lubricant should be used during routine maintenance (e.g. after each patient use and prior to sterilization). In order to avoid the risk, user must buy and use specified lubricant type "PANA SPRAY Plus" manufactured by NAKANISHI INC (cleared in K163483).

AI/ML Overview

The provided document describes a 510(k) premarket notification for a Class I medical device, the Dental High-speed Turbine Handpiece. The document details the device's substantial equivalence to legally marketed predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding detailed acceptance criteria and a study to prove them is not applicable in this context.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide specific numerical acceptance criteria for performance in a clinical sense. Instead, it compares the subject device's specifications and performance to predicate devices and adherence to relevant standards.

Acceptance Criteria (Inferred from comparison to predicates and standards)	Reported Device Performance (Subject Device)	Predicate Device Performance (K152146)	Note on Comparison
Indications for Use	Removing carious material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.	Removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.	Substantially Equivalent (SE)
Operational Modes	Air-powered	Air-powered	SE
Water Spray	Single/Triple	Single/Triple	SE
Type of Chuck	Push button, Screw	Push button	SE (Predicate K141886 includes both types, and both are mechanically safe)
Composition of Main Materials	Stainless Steel, Brass, Titanium	Stainless steel, Brass, Aluminum, Titanium	SE (Differences are compliant with ISO 10993-1)
Bur Extraction Force	28N	22N~45N	SE (Compliant with ISO 14457)
Operating Pressure	177KPa ~ 301KPa	200KPa	SE (Compliant with ISO 14457)
Rotation Speed	300,000rpm ~ 400,000rpm	350,000rpm ~ 400,000rpm	SE (Compliant with ISO 14457)
Sterilization	Steam autoclave method	Steam autoclave method	SE
Compliance Standards	ISO 10993-5, ISO 10993-10, ISO 14457	Not explicitly listed for predicate, but generally compliant.	SE (Subject device complies)

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

Sample Size for Test Set: Not applicable. This is not a clinical study assessing patient outcomes or device performance on a test set of data/patients. The "test set" here refers to the physical device being tested against engineering standards.
Data Provenance: Not applicable in the context of clinical data. The performance claims are based on engineering tests and comparisons to predicate devices, not clinical data sets.

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

Not applicable. Ground truth as typically understood in AI/clinical studies (e.g., expert consensus on diagnostic images) is not relevant for this type of device submission. The "ground truth" for this device is established through compliance with recognized standards and successful engineering tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. There is no clinical adjudication of results for a test set.

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 device is a dental handpiece, not an AI-assisted diagnostic tool.

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

Not applicable. This device does not involve an algorithm.

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

Type of Ground Truth: The "ground truth" for the device's safety and effectiveness is established through adherence to ISO standards (ISO 14457 for performance, ISO 10993-1 for biocompatibility, ISO 17665:2006 and ISO 11134:2003 for sterilization), and reprocessing validation according to FDA guidance. It is also based on demonstrating substantial equivalence to existing legally marketed devices.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable.

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Guangdong JINME Medical Technology Co., Ltd. % Cassie Lee Vice President Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park Guangzhou, 510663 CN

November 8, 2017

Re: K170229

Trade/Device Name: Dental High-speed Turbine Handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I Product Code: EFB Dated: September 30, 2017 Received: October 10, 2017

Dear Cecilia Ceng:

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Mary S. Runner -S

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K170229

Device Name Dental High-speed 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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Guangdong JINME Medical Technology Co., Ltd. Sponsor: Dental High-speed Turbine Handpiece, Models: T, S, TU, SU, TP, SP, TUQ, Subject Device: TUP, SUP, SUQ, TUQP, SUQP File No.: 510(k) Submission Report (V1.0), Chapter 6. 510(k) Summary

510(k) Summary K170229

1. Submitter's Information

Company Name: Guangdong JINME Medical Technology Co., Ltd.

Establishment registration number: Applying

Address: A15, New Light Source Industrial Base, Nanhai District, Foshan, Guangdong, China

Name of contact person: Kristi Yang

Title: Manager

Tel: 86-757-88777997

Fax: 86-757-81267508

E-mail: kristi@jinmedental.com

Application Correspondent:

Contact Person: Ms. Cassie Lee

Guangzhou GLOMED Biological Technology Co., Ltd. Address: Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park, Guangzhou 510663, China Tel: +86-20-61099984 E-mail: regulatory@glomed-info.com

2. Subject Device Information:

Type of 510(k) Submission: Traditional Common Name: Dental Handpiece

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Sponsor: Guangdong JINME Medical Technology Co., Ltd. Dental High-speed Turbine Handpiece, Models: T, S, TU, SU, TP, SP, TUQ, Subject Device: TUP, SUP, SUQ, TUQP, SUQP 510(k) Submission Report (V1.0), Chapter 6. 510(k) Summary File No.:

Trade Name: Dental High-speed Turbine Handpiece Models: T, S, TU, SU, TP, SP, TUQ, TUP, SUP, SUQ, TUQP, SUQP Classification Name: Dental Handpiece and accessories Product Code: EFB Regulation Number: 21CFR 872.4200 Regulation Class: 1

3. Predicate Device Information:

Predicate Device: K152146 Company Name: Codent Technical Industry Co., Ltd. Trade Name: High Speed Handpiece and Accessories Common Name: Dental Handpiece and Accessories Product Code: EFB

Reference Device: K141886 Company Name: Modern Korea Co., Ltd. Trade Name: MDK Handpieces Common Name: Dental Handpiece and Accessories Product Code: EFB
Reference Device: K163483 Company Name: NAKANISHI, INC. Trade Name: Pana Spray Plus Common Name: Dental Handpiece and Accessories Product Code: EFB

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Sponsor:	Guangdong JINME Medical Technology Co., Ltd.
Subject Device:	Dental High-speed Turbine Handpiece, Models: T, S, TU, SU, TP, SP, TUQ,TUP, SUP, SUQ, TUQP, SUQP
File No.:	510(k) Submission Report (V1.0), Chapter 6. 510(k) Summary

4. Device Description

The handle is slide-proof, comfortable and easy to clean. Handpiece and adaptors can bear steam disinfection at 135°C. The head angle can provide better operational vision and and efficiency can be improved. Cartidges have high precision when rotating, cartiridges have low noise and high efficiency. The scope of application: for dental professional use only.

Lubricant should be used during routine maintenance (e.g. after each patient use and prior to sterilization).

In order to avoid the risk, user must buy and use specified lubricant type "PANA SPRAY Plus" manufactured by NAKANISHI INC (cleared in K163483).

5. Intended Use / Indications for Use

6. Test Summary

Dental High-speed Turbine Handpiece is designed, tested and will be manufactured in accordance with both mandatory and voluntary standards, including:

Performance test according to ISO 14457 standard

Biocompatibility test according to ISO 10993-1 standard

Sterilization test according to ISO 17665:2006 and ISO 11134:2003 standards

Reprocessing validation according to FDA guidance document Dental Handpieces - Premarket Notfications on

The result of tests indicates that the Dental High-speed Turbine is substantially equivalent to the legally marketed predicate device.

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Sponsor:	Guangdong JINME Medical Technology Co., Ltd.
Subject Device:	Dental High-speed Turbine Handpiece, Models: T, S, TU, SU, TP, SP, TUQ,TUP, SUP, SUQ, TUQP, SUQP
File No.:	510(k) Submission Report (V1.0), Chapter 6. 510(k) Summary

7. Comparison to predicate device and conclusion

Elements ofComparison	Subject Device	Predicate Device (Primary)	Reference Device	Reference Device	Remark
Manufacturer	Guangdong JINMEMedical Technology Co.,Ltd.	Codent Technical IndustryCo., Ltd.	Modern Korea Co., Ltd.	NAKANISHI, INC.	--
Device Name	Dental High-speed TurbineHandpiece	High Speed Handpieces andAccessories	MDK Handpieces	Pana Spray Plus	--
Model	T, S, TU, SU, TP, SP,TUQ, TUP, SUP, SUQ,TUQP, SUQP	A45 series, A6 series, A5series, A4 series, A3 series,E-6510 series, E-6500series, E-6110 series, E-6100 series, HPX series,HPM series, HPK series	--	--	--
510(k) Number	K170229	K152146	K141886	K163483	--
Product Code	EFB	EFB	EFB	EFB	SE
Indications forUse& IntendedUse	Dental High-speed TurbineHandpiece is intended forremoving carious material,excess filling material,cavity and crownpreparation, finishing toothpreparations andrestorations, root canalpreparations and polishingteeth.	High Speed Handpieces andAccessories are intended forremoving carious material,excess filling material, cavityand crown preparation,finishing tooth preparationsand restorations, root canalpreparations and polishingteeth.	MDK high-speedhandpieces are used forthe removal of cariousmaterial, reducing of hardtooth structure, cavity andcrown preparations,removal of fillings,processing and finishingtooth preparations,restorations, and forpolishing teeth.MDK low-speedhandpieces used for teethcutting, cavity and crownpreparation, restorationsand polishing teeth.All the devices aredesigned for use by atrained professional in thefield of general dentistry.	PANA SPRAY Plus is alubricant to be used duringroutine maintenance ofdental and medicalsurgical handpieces aftereach patient use and priorto sterilization and isintended for use to cleanand lubricate the dentaland medical surgicalhandpieces.	SENote 4
OperationalModes	Air-powered	Air-powered	Air-powered	--	SE
Water Spray	Single/Triple	Single/Triple	--	--	SE
Type of Chuck	Push button, Screw	Push button	Push button, Latch, Screw,Snap-on or tip-lock chuckoptions	--	SENote 1
Composition ofMain Materials	Stainless Steel, Brass,Titanium	Stainless steel, Brass,Aluminum, Titanium	Stainless Steel, Titanium	--	SENote 2
Bur ExtractionForce	28N	22N~45N	--	--	SENote 3
OperatingPressure	177KPa ~ 301KPa	200KPa	--	--	SENote 3
Rotation Speed	300,000rpm ~ 400,000rpm	350,000rpm ~ 400,000rpm	--	--	SENote 3

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Sponsor:	Guangdong JINME Medical Technology Co., Ltd.
Subject Device:	Dental High-speed Turbine Handpiece, Models: T, S, TU, SU, TP, SP, TUQ,TUP, SUP, SUQ, TUQP, SUQP
File No.:	510(k) Submission Report (V1.0), Chapter 6. 510(k) Summary

Sterilization	Steam autoclave method	Steam autoclave method	--	--	SE
ComplianceStandards	Complied with ISO 10993-5, ISO 10993-10,ISO14457	--	--	--	SENote 2
Lubricant	The specified lubricant,type "PANA SPRAY Plus"manufactured byNAKANISHI INC (clearedin K163483), must be usedduring routinemaintenance.	--	--	Lubricant "PANA SPRAYPlus" manufactured byNAKANISHI INC	SENote 4

Comparison in Detail

Note 1:

Although the "Type of Chuck" of subject device is a little different from predicate K141886 includes all the chunk types (Push Button Type, Screw Type) of subject device. And "Push Button Type" are both have safety mechanical performance for air-powered handpiece.

Note 2:

Although the main materials of subject devices are a little difference from predicate devices are compliance with ISO 10993-1.

Note 3:

Although the subject devices are a little difference from predicate devices in Bur Extraction Force, Operating Pressure, Rotation Speed, Compliance Standards; the subject devices are compliance with "ISO 14457:2012 Dentistry - Handpieces and Motors".

Note 4:

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The user need to buy and use the specified lubricant, type "PANA SPRAY Plus" (cleared in K163483) manufactured by NAKANISHI NC, during routine maintenance.

Finial conclusion:

The subject device Dental High-speed Turbine Handpiece (Models: T, S, TU, TUP, SUP, SUQ, TUQP, SUQP) has all features of predicate devices. The differences between them do not raise new questions of safety and effectiveness. Thus, the subject device is substantially equivalent to the predicate device.

Date of the summary prepared: November 7, 2017

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.