K Number

Device Name

Dental High-speed Turbine Handpiece

Manufacturer

GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD.

Date Cleared

2017-11-08

(287 days)

Product Code

EFB

Regulation Number

872.4200

Intended Use

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).

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K152146

Reference Devices

K141886, K163483

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical and sterilization properties, with no mention of AI or ML capabilities.

Therapeutic

Yes
The device is described as an instrument for "drilling, grinding, repairing" and is used for "removing carious material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth," which are all therapeutic procedures aiming to treat dental issues.

Diagnostic

This device is a Dental High-speed Turbine Handpiece, which is used for treatment procedures like removing carious material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth. These are all interventional or treatment-related uses, not diagnostic ones.

SaMD (Software as a Medical Device)

The device description explicitly states it is composed of a handpiece and a connector, and describes physical characteristics and sterilization requirements, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a device used for physical procedures on teeth (removing material, preparing cavities, polishing, etc.). This is a surgical/dental instrument, not a device used to examine specimens in vitro (outside the body) to obtain diagnostic information.
Device Description: The description focuses on the mechanical aspects of the handpiece and its function in drilling, grinding, and repairing teeth. It doesn't mention any components or processes related to analyzing biological samples.
Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There are no reagents, test strips, or analytical methods described.

Therefore, this device falls under the category of a dental instrument used for treatment, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

EFB

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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

for dental professional use only.

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)

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.

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

Not Found

Predicate Device(s)

K152146

Reference Device(s)

K141886, K163483

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

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

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

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

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

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

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.

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 of

Comparison	Subject Device	Predicate Device (Primary)	Reference Device	Reference Device	Remark
Manufacturer	Guangdong JINME
Medical Technology Co.,
Ltd.	Codent Technical Industry
Co., Ltd.	Modern Korea Co., Ltd.	NAKANISHI, INC.	--
Device Name	Dental High-speed Turbine
Handpiece	High Speed Handpieces and
Accessories	MDK Handpieces	Pana Spray Plus	--
Model	T, S, TU, SU, TP, SP,
TUQ, TUP, SUP, SUQ,
TUQP, SUQP	A45 series, A6 series, A5
series, A4 series, A3 series,
E-6510 series, E-6500
series, 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 for
Use& Intended
Use	Dental High-speed 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.	High Speed Handpieces and
Accessories are intended for
removing carious material,
excess filling material, cavity
and crown preparation,
finishing tooth preparations
and restorations, root canal
preparations and polishing
teeth.	MDK high-speed
handpieces are used for
the removal of carious
material, reducing of hard
tooth structure, cavity and
crown preparations,
removal of fillings,
processing and finishing
tooth preparations,
restorations, and for
polishing teeth.
MDK low-speed
handpieces used for teeth
cutting, cavity and crown
preparation, restorations
and polishing teeth.
All the devices are
designed for use by a
trained professional in the
field of general dentistry.	PANA SPRAY Plus is a
lubricant to be used during
routine maintenance of
dental and medical
surgical handpieces after
each patient use and prior
to sterilization and is
intended for use to clean
and lubricate the dental
and medical surgical
handpieces.	SE
Note 4
Operational
Modes	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 chuck
options	--	SE
Note 1
Composition of
Main Materials	Stainless Steel, Brass,
Titanium	Stainless steel, Brass,
Aluminum, Titanium	Stainless Steel, Titanium	--	SE
Note 2
Bur Extraction
Force	28N	22N~45N	--	--	SE
Note 3
Operating
Pressure	177KPa ~ 301KPa	200KPa	--	--	SE
Note 3
Rotation Speed	300,000rpm ~ 400,000rpm	350,000rpm ~ 400,000rpm	--	--	SE
Note 3

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	--	--
Compliance
Standards	Complied with ISO 10993-
5, ISO 10993-10,
ISO14457	--	--	--	SE
Note 2
Lubricant	The specified lubricant,
type "PANA SPRAY Plus"
manufactured by
NAKANISHI INC (cleared
in K163483), must be used
during routine
maintenance.	--	--	Lubricant "PANA SPRAY
Plus" manufactured by
NAKANISHI INC	SE
Note 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:

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