Dental High-speed Turbine Handpiece (WJ-114, WJ-122, WJ-124, WJ-134, WJ-132, WJ-144, WJ-142, WJ -154, WJ -162, WJ -162) is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth. Dental Low-speed Turbine Handpiece (WJ-414, WJ-424, WJ-422) is intended for removing carious material, excess filling material, cavity and crown preparations and restorations and restorations, root canal preparations and polishing teeth.

Device Description

The Dental High-speed Turbine Handpiece is the dental clinic, hospital treatment for patients with tooth disease tools, which is an instrument for drilling, grinding, repairing. It composed of handpiece and a connector, including models WJ-114, WJ-112, WJ-124, WJ-134, WJ-132, WJ-144, WJ -142, WJ -154, WJ -152, WJ -164, WJ -162.
The Dental Low-speed Handpiece is the dental clinic, hospital treatment for patients with tooth disease tools, which is an instrument for drilling, grinding, repairing. It composed of handpiece and a connector, including low speed air motor, straight handpiece and geared angle handpiece, for the model WJ-414, WJ-412, WJ-424, WJ-422

AI/ML Overview

This document is a 510(k) summary for a dental handpiece, not a study report. It aims to demonstrate substantial equivalence to predicate devices, not to prove the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not present in this type of regulatory submission.

However, based on the provided text, I can extract information about performance tests conducted to support substantial equivalence, which implicitly serve as acceptance criteria for functionality and safety.

Here's a breakdown of the available information and why other requested details are not present:

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

The document doesn't present explicit "acceptance criteria" in a numerical or pass/fail table format, as one might find in a clinical study report for a diagnostic device. Instead, it relies on performance tests aligning with recognized standards to demonstrate substantial equivalence to predicate devices. The "Elements of Comparison" table (pages 6-7) serves a similar purpose by comparing the subject device's characteristics against predicate devices, implying that if the subject device meets or is comparable to the predicate's performance/specifications, it is acceptable.

Below is an attempt to create a table based on the provided "Test Summary" and "Elements of Comparison", reinterpreting compliance with standards and equivalence to predicate devices as meeting "acceptance criteria".

Acceptance Criteria Category (Implicit)	Specific Standard/Characteristic	Subject Device Performance/Status
Biocompatibility	Cytotoxicity, Sensitization, Irritation	Complied with ISO 10993-5 and ISO 10993-10 standards
Performance (Functional)	Dental Handpiece Performance	Complied with ISO 14457:2012 standards
Electrical Safety	Medical Electrical Equipment	Complied with IEC 60601-2-60 standards (and IEC 60601-1 for fiberoptic models)
Sterilization & Cleaning Validation	Reprocessing Validation	Complied with ISO 17665-1, ISO 17665-2, ASTM ST79, and FDA Guidance Document "Reprocessing Medical Devices..."
Bur Extraction Force	Minimum Force	28N (Compared to predicate's 28N and 30N)
Maximum Air Pressure (High-speed)	Operating Range	200kPa ~ 250kPa (29.01 psi~ 36.25 psi) (Comparable to predicate's 177kPa ~ 301kPa)
Maximum Air Pressure (Low-speed)	Operating Range	245 ~ 392 kPa (35.53 psi~ 56.85 psi) (Comparable to predicate's 245 ~ 392 kPa and 36-43psi)
Speed in RPMs (High-speed)	Operating Range	300,000rpm ~ 400,000rpm (Comparable to predicate's 300,000-400,000rpm and 320,000-400,000rpm)
Speed in RPMs (Low-speed)	Operating Range	18,000 ~ 20,000 rpm (Comparable to predicate's 18,000-22,000rpm and up to 20,000rpm)
Conformity with Shanks	Type of Shanks	Type 3 per ISO 1797-1
Coupling Dimensions	Standard Compliance	Complied with ISO 3964
Hose Connections	Type of Connections	Type 1 for 2-hole model / Type 2 for 4-hole model

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. Performance tests typically involve laboratory testing of a small number of device samples rather than human subject test sets. The document states "Performance testing was provided," but doesn't detail the number of units tested for each standard. Data provenance is also not mentioned, but given the manufacturer's location (Foshan, China), it's highly likely tests were conducted in China or by certified labs on behalf of the manufacturer. These are not "test sets" in the clinical study sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable and not provided. This document describes premarket notification for a Class I dental handpiece, which typically involves demonstrating substantial equivalence through engineering, performance, and biocompatibility testing against recognized standards and predicate devices, not clinical trials requiring expert-established ground truth. Expert review, if any, would be for the regulatory submission itself by the FDA, not for establishing ground truth for device performance data (which comes from lab tests).

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

This is not applicable and not provided. Adjudication methods are relevant for clinical studies where multiple experts evaluate ambiguous outcomes. This document details laboratory and performance testing, which does not involve this kind of adjudication.

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

This is not applicable and not provided. MRMC studies are used for diagnostic devices, particularly those involving image interpretation by human readers, often with AI assistance. This device is a dental handpiece (a surgical/treatment tool), not a diagnostic or AI-assisted interpretation system.

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

This is not applicable and not provided. This refers to AI algorithm performance. The device is a mechanical dental instrument.

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

This is not applicable in the context of this device and report. For the performance tests conducted, the "ground truth" would be the specification limits defined by the relevant ISO and IEC standards (e.g., a specific bur retention force, a defined RPM range). For biocompatibility, it's compliance with established biological safety requirements.

8. The sample size for the training set

This is not applicable and not provided. "Training set" refers to data used to train machine learning algorithms. This device is a mechanical tool.

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

This is not applicable and not provided. See point 8.

Summary

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May 26, 2020

Foshan Wenjian Medical Instrument Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park Guangzhou, Guangdong, 510663 CHINA

Re: K181691

Trade/Device Name: High-speed air turbine handpiece / Low-speed air turbine handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I, reserved Product Code: EFB, EGS Dated: April 9, 2020 Received: April 27, 2020

Dear Cassie Lee:

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,

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) K181691

Device Name

High-speed air turbine handpiece / Low-speed air turbine handpiece

Indications for Use (Describe)

and polishing teeth.

Type of Use (Select one or both, as applicable)
\u2612 Prescription Use (Part 21 CFR 801 Subpart D)	\u2610 Over-The-Counter Use (21 CFR 801 Subpart C)

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K181691

510(k) Summary Date Prepared: May 22, 2020

1. Submitter's Information

Name of Sponsor: Foshan Wenjian Medical Instrument Co., Ltd. Address: Third Floor, No.3, Jiebian Industrial Zone, LuoCun, ShiShan Town, Nanhai, Foshan City, Guangdong, China Contact Name (Title): Wen Huang (Manager) Telephone No.: 86-757-81801258 Email: 1191837402@gqq.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 Email: regulatory@glomed-info.com

2. Subject Device Information:

Common Name: Dental Handpiece and Accessories Trade Name: High-speed air turbine handpiece / Low-speed air turbine handpiece Model: Dental High-speed Turbine Handpiece (WJ-114, WJ-112, WJ-122, WJ-134, WJ-134, WJ -144, WJ -142, WJ -154, WJ -152, WJ -164, WJ -162) Dental Low-speed Turbine Handpiece (WJ-414, WJ-412, WJ-422) Classification Name: Dental Handpiece and Accessories Review Panel: Dental Product Code: EFB, EGS Regulation Class: 1 Regulation Number: 21 CFR 872.4200

3. Predicate Device Information:

Primary Predicate: (K170229)

Company Name: Guangdong JINME Medical Technology Co., Ltd. Common Name: Dental Handpiece and Accessories Trade Name: Dental High-speed Turbine Handpiece Product Code: EFB Regulation Class: 1

Reference Device 1: (K170236)

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Company Name: Guangdong JINME Medical Technology Co., Ltd. Common Name: Dental Handpiece and Accessories Trade Name: Dental Low-speed Turbine Handpiece Product Code: EFB, EGS Regulation Class: 1

Reference Device 2: (K141886)

Company Name: Modern Korea Co., Ltd. Trade Name: MDK Handpieces Classification Name: Dental Handpiece and Accessories Product Code: EFB Regulation Class: 1

4. Device Description

� Dental High-speed Turbine Handpiece

For the model name which including: WJ represent for branch name.

WJ-1XX represent for Dental High-speed Turbine Handpiece;

WJ-XX2 represent for model which included 2-hole (drive air and water holes);

WJ-XX4 represent for model which included 4-hole coupling (drive air, exhaust air, spray air and spray water holes);

Handpiece are able to run 300000 to 400000 rpm.

Handpiece and adaptors can bear steam disinfection at 135°C. 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).

� Dental Low-speed Turbine Handpiece

The Dental Low-speed Handpiece is the dental clinic, hospital treatment for patients with tooth disease tools, which is an instrument for drilling, grinding, repairing. It composed of handpiece and a connector, including low speed air motor, straight handpiece and geared angle handpiece, for the model WJ-414, WJ-412, WJ-424, WJ-422

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The gear ratios of handpieces have a various gear ratio (for different geared angle handpiece) (1:1 (constant), 20:1 (speed reduction) and 1:5 (speed increase));

The handpieces have maximum Forward rotation speed 19000 rpm and maximum Reverse rotation speed of 18000 rpm.

The air motors are capable of running up to a speed of 22000 rpm, but different pressure of air supply.

Handpiece and adaptors can bear steam disinfection at 135°C. Coupling is the accessory for handpiece to connect with tubes of dental unit. It could be divided into three types. It included 2-hole (drive air and water holes) and 4-hole coupling (drive air, exhaust air, spray air and spray water holes). The use of the coupling of handpiece is due to the number of tubes of dental unit. 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

Dental High-speed Turbine Handpiece (WJ-112, WJ-124, WJ-122, WJ-134, WJ-132, WJ -144, WJ -142, WJ -154, WJ -152, WJ -164, WJ -162) is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

Dental Low-speed Turbine Handpiece (WJ-414, WJ-412, WJ-422) is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

6. Test Summary

High-speed air turbine handpiece / Low-speed air turbine handpiece is designed, tested and will be manufactured in accordance with both mandatory and voluntary standards. Performance testing was provided including:

Cytotoxicity, sensitization, and irritation biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
Performance test according to ISO 14457:2012 standards.
Medical electrical equipment test according to IEC 60601-2-60 standards
Sterilization and cleaning validation per ISO 17665-1, ISO 17665-2, ASTM ST79, and the FDA Guidance Document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling"

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The result of tests indicates that the Dental Handpiece and Accessories has substantial equivalent performance as the legally marketed predicate device.

ElementsofComparison	Subject Device	PrimaryPredicate	ReferenceDevice 1	ReferenceDevice 2	Remark
Manufacturer	Foshan WenjianMedical InstrumentCo., Ltd.	GuangdongJINME MedicalTechnology Co.,Ltd.	GuangdongJINME MedicalTechnologyCo., Ltd.	Modern KoreaCo. Ltd.	--
DeviceName	High-speed airturbine handpiece /Low-speed airturbine handpiece	Dental High-speed TurbineHandpiece	Dental Low-speed TurbineHandpiece	MDKHandpieces	--
Model	Dental High-speedTurbine Handpiece(WJ-114, WJ- 112,WJ-124, WJ -122,WJ-134, WJ -132, WJ -144, WJ-142, WJ -154, WJ -152,WJ -164, WJ -162)Dental Low-speedTurbine Handpiece(WJ-414, WJ- 412,WJ-424, WJ-422)	T, S, M, TU, SU,MU, TP, SP,TUQ, TUP, SUP,SUQ, TUL, SUL,TUQL, SUQL,TUQP, SUQP,45- T,45-TU,45-TUQ	LN, L	--	--
510(k)Number	K181691	K170229	K170236	K141886	--
ProductCode	EFB, EGS	EFB	EFB, EGS	EFB	SE
Indicationsfor Use&IntendedUse	Dental High-speedTurbine Handpiece(WJ-114, WJ- 112,WJ-124, WJ -122,WJ-134. WJ -132. WJ -144, WJ-142, WJ -154, WJ -152,WJ -164, WJ -162) isintended forremoving cariousmaterial, excessfilling material, cavityand crownpreparation, finishingtooth preparationsand restorations, rootcanal preparationsand polishing teeth.Dental Low-speed	Dental High-speed TurbineHandpiece isintended forremoving cariousmaterial, excessfilling material,cavity and crownpreparation,finishing toothpreparations andrestorations, rootcanalpreparations andpolishing teeth.	Dental Low-speed TurbineHandpiece isintended forremovingcariousmaterial, excessfilling material,cavity andcrownpreparation,finishing toothpreparationsandrestorations,root canalpreparationsand polishingteeth.	MDK high-speedhandpiecesare used forthe removal ofcariousmaterial,reducing ofhardtoothstructure,cavity andcrownpreparations,removal offillings,processingand finishingtoothpreparations,restorations,	SENote 1

	Turbine Handpiece(WJ-414, WJ- 412,WJ-424, WJ-422) isintended forremoving cariousmaterial, excessfilling material, cavityand crownpreparation, finishingtooth preparationsand restorations, rootcanal preparationsand polishing teeth.			and forpolishingteeth.MDK low-speedhandpiecesused for teethcutting, cavityand crownpreparation,restorationsand polishingteeth.All the devicesare designedfor use by atrainedprofessional inthe field ofgeneraldentistry.
Air/waterports	2/4 ports	2/4 ports	2/4 ports	Up to four	SE
FiberopticGlass Rod	Included in modelWJ-162, WJ-164,WJ-424 and WJ-422	N/A	N/A	Yes (11models)No (10models)	SENote 2
Dimensions	Refer to table 1	N/A	N/A	N/A	SENote 3
Accessories	N/A	N/A	N/A	High-speedhandpiecesWrench,Connector (forinsertinglubricant)Low-speedhandpiecesHead openerfor the latchtype,Connector forinsertinglubricant,ExternalSpray Tubingwith nozzle	SENote 4
Composition of material	Stainless steel,Brass, Aluminum,Titanium	Stainless steel,Brass.Aluminum,Titanium	Stainless Steel,Brass, Titanium	Stainless steeland titanium	SE
Chuck	Push button, Screw	Push button,Screw	Push buttonLatch-typechuck	push button,latch, screw,snap-on or tip-lock chuckoptions	SE
Burextractionforce	28N	28N	--	30N	SE
Maximumair pressure	Dental High-speedTurbine Handpiece:200kPa ~ 250kPa(29.01 psi~ 36.25psi)Dental Low-speedTurbine Handpiece:245 ~ 392 kPa(35.53 psi~ 56.85psi)	177kPa ~~301kPa (25.67psi~~ 45.66psi)	245 ~ 392 kPa(35.53 psi~56.85psi)	36psi to 43psi	SENote 3
Maximumwaterpressure	Dental High-speedTurbine Handpiece:200kPa ~ 250kPa(29.01 psi~ 36.25psi)Dental Low-speedTurbine Handpiece:245 ~ 392 kPa(35.53 psi~ 56.85psi)
Speed inrpms	Dental High-speedTurbine Handpiece:300,000rpm ~400,000rpmDental Low-speedTurbine Handpiece:18,000 ~20,000 rpm	300,000rpm ~400,000rpm	18,000 ~22,000rpm	High-speedhandpieces320,000 ~400,000rpmLow-speedhandpiecesUp to 20,000rpm	SENote 3
Conformance withstandardsforshanks	Type 3 per ISO1797-1	Type 3 per ISO1797-1	Type 3 per ISO1797-1	N/A	SE
Couplingdimensions	Complied with ISO3964	N/A	Complied withISO 3964	N/A	SE
Hoseconnections	Type 1 for 2-holemodel / Type 2 for 4-hole model	Type 1 for 2-holemodel / Type 2for 4- hole model	Type 1 for 2-hole model /Type 2 for 4-hole model	N/A	SE
Lubricant	The specifiedlubricant, type"PANA SPRAY Plus"manufactured byNAKANISHI INC(cleared inK163483), must beused during routinemaintenance.	The specifiedlubricant, type"PANA SPRAYPlus"manufactured byNAKANISHI INC(cleared inK163483), mustbeused duringroutinemaintenance.	The specifiedlubricant, type"PANA SPRAYPlus"manufacturedby NAKANISHIINC(cleared inK163483), mustbeused duringroutine	Pana-Spraymade byNSK(K052700)	SENote 5
			maintenance.
ComplianceStandards	Complied with ISO10993-5, ISO10993-10, IEC60601-1, IEC 80601-2-60, ISO14457, ISO17665, ISO 11138,ISO 11607, ISO17664	Complied withISO 10993-5,ISO 10993-10, ISO14457	Complied withISO 10993-5,ISO10993-10,ISO14457	Complied withISO 17665,ISO 11138,ISO 11135,ISO11607,ISO 17664,and USP 30-NF 25,ISO14457, ISO10993-5	SENote 6

7. Comparison to predicate device and conclusion

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Comparison in Detail

Note 1:

Although the subject devices are a little difference from predicate devices in "Intended Used", but it's the combination of predicate devices K170229 and K170236. And it's the same with K141886. So, the difference will not raise any substantial equivalence issue.

Note 2:

Although the subject devices are a little difference from predicate devices in "Fiberoptic" glass rod to transmit light, but the subject devices are compliance with safety standard IEC 60601-1 instead. But it's the same with K141886. So the difference will not raise any substantial equivalence issue.

Note 3:

Although the subject devices are a little difference from predicate devices in "Dimensions", "Maximum air pressure", "Maximum water pressure" and "Speed in rpms", the subject devices are it's the features combination of predicate devices K170229 and K170236 and K141886. So, the difference will not raise any substantial equivalence issue.

Note 4:

The subject devices are a little difference from predicate devices in "Accessories" with K141886, but it's the same with the predicate devices K170229 and K170236. The accessories in predicate devices are mainly tools for cleaning handpieces. Not part of predicate devices. So the accessories do not affect the product performance. So, the difference will not raise any substantial equivalence issue.

Note 5:

The subject devices are a little difference from predicate devices in "Lubricant", but the Lubricant is only used for lubrication. As long as it meets the requirements and is FDA cleared, Lubricant can achieve lubrication.

Therefore, which brand of Lubricant is used does not affect the performance of the device. So, the difference will not raise any substantial equivalence issue.

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Note 6:

The common sterilization method of dental handpieces is steam sterilization, because the structure and material characteristics of dental handpieces:. The common dental handpieces sterilization method in the market is also steam sterilization. Therefore, ISO 17665 is applicable standard for verification of steam sterilization. The sterilization method adopted by the subject device is the commonly used steam sterilization. Because the sterilization USES steam, there is no other harmful residue after sterilization. Therefore, there is no need to refer to ISO 11135 and USP 30-NF25 for subject device. So, the difference will not raise any substantial equivalence issue.

Finial conclusion:

The subject device Dental High-speed Turbine Handpiece (WJ-114, WJ-124, WJ -122, WJ- 134, WJ -132, WJ -144, WJ -142, WJ -154, WJ -152, WJ -164, WJ -162), Dental Low-speed Turbine

Handpiece (WJ-414, WJ-412, WJ-424, WJ-422) has all features of predicate devices. Thus, the subject device is substantially equivalent to the predicate device.

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.