A dental contra-angle handpiece that attaching a vertical reciprocating dental strips intended to be used in interproximal reduction of teeth; And it is part of orthodontic treatment of finishing interdental and subgingival area, finishing cavity edges, removing the dentin of teeth adjacent, removing subgingival plague and tripping. The device incorporates a small micro motor normally driven by compressed air; This is a reusable device.

Device Description

The OK handpiece is a reciprocating contra-angle handpiece that is used in connection with an air motor. The rotational force of the air motor is transmitted to the handpiece head through the shaft of the handpiece body, and the rotational force of the shaft is converted into vertical reciprocating motion in the head. The OK handpiece is a reprocessing medical device. Users must steam sterilize before each use, and clean thoroughly after use. The OK handpiece does not have water/air spray and light supply. Therefore, the air motor connection of the handpiece is designed to comply with the coupling size of TYPE 1 of ISO 3964. For the strip connecting to the OK handpiece, you must use Orthok-Strips and OK Proxofile of Jaintek Co., Ltd.

AI/ML Overview

The provided text (K221814) describes the 510(k) premarket notification for the "OK Handpiece," a dental contra-angle handpiece. This device is classified as a Class I medical device (21 CFR 872.4200) and is cleared based on substantial equivalence to predicate devices, not requiring extensive clinical trials typically associated with novel or higher-risk devices.

Therefore, the acceptance criteria and the study that proves the device meets the acceptance criteria are based on non-clinical performance testing and compliance with relevant standards, rather than complex clinical studies involving human readers or AI algorithms.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance for the OK Handpiece (K221814)

This device, a dental handpiece, demonstrates substantial equivalence through non-clinical bench testing and compliance with recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance	Comments/Justification
Bench Testing - Physical/Mechanical Performance
Motor Coupling Compatibility	ISO 3964:2016 (Dentistry -- Coupling dimensions for handpiece connectors)	Complies with ISO 3964 TYPE 1 coupling size.	Ensures compatibility with standard air motors.
General Handpiece Standards	ISO 14457:2017 (Dentistry - Handpieces and motors)	Complies with the standard.	Demonstrates overall mechanical and safety performance for handpieces.
Bur Extraction Force	$\ge$ 22N (as per manufacturer's internal criteria, implied from comparison table)	$\ge$ 22N	Exceeds or meets necessary force to retain dental stripping instruments. Not directly comparable to predicates due to missing data for predicates, but demonstrates compliance with requirements.
Biocompatibility	ISO 10993-1:2018 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process)	Evaluated per standard.	Confirms material safety for patient contact.
In vitro Cytotoxicity	ISO 10993-5:2009 (Tests for in vitro cytotoxicity)	Passed.	No cytotoxic effects from the material.
Skin Sensitization	ISO 10993-10:2010 (Tests for irritation and skin sensitization)	Passed.	No allergic or sensitization reactions.
Oral Mucosa Irritation	ISO 10993-10:2010 (Tests for irritation and skin sensitization - Oral mucosa specific)	Passed.	No irritation to oral tissues.
Sterilization
Sterility Assurance Level (SAL)	1E-6	Achieved 1E-6 SAL.	Confirms effective sterilization when performed by end-user per instructions.
Moist Heat Sterilization Validation	ISO 17665-1:2006 (Sterilization of health care products - Moist heat - Part 1)	Verified per standard.	Confirms the sterilization process used for validation is adequate.
Guidance on Application of ISO 17665-1	ISO/TS 17665-2:2009 (Sterilization of health care products - Moist heat - Part 2)	Verified per standard.	Follows guidance for moist heat sterilization.
Biological Indicators	ISO 11138-1:2017 (Sterilization of health care products - Biological indicators - Part 1)	Verified per standard.	Ensures proper use and assessment of biological indicators.
Microbiological Methods	ISO 11737-1:2018 (Sterilization of medical devices - Microbiological methods - Part 1)	Verified per standard.	Confirms appropriate methods for determining microorganism population.
Steam Sterilization Guidance	ANSI/AAMI ST79:2017 (Comprehensive guide to steam sterilization and sterility assurance in health care facilities)	Verified per standard.	Adheres to comprehensive guidelines for steam sterilization in healthcare.
Material Composition	Biocompatible raw materials (e.g., 304 Stainless Steel)	Manufactured from 304 stainless steel.	Confirmed as suitable through biocompatibility evaluation.

Study Information (Based on a Non-Clinical Device)

Given that this is a Class I dental handpiece, the "study" is primarily a series of non-clinical bench tests and adherence to recognized international standards. The device is not software-based or image-analyzing AI, so many of the requested items related to AI/MRMC studies are not applicable.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated as a "sample size" in the context of clinical data for a handpiece. Performance was verified on the device itself against standard requirements. For physical testing (e.g., bur extraction force, durability), usually a representative sample of manufactured devices would be tested to demonstrate consistency with design specifications. The document implies that "the proposed device" met the specifications, suggesting testing was performed on actual devices.
Data Provenance: The tests were non-clinical bench tests conducted to "verify that the proposed device met all design specifications" and demonstrated compliance with ISO standards. There is no mention of country of origin for test data, as it's performed to international standards. It's an engineering validation, not data from patients.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable as this is a physical device undergoing non-clinical testing against engineering and material standards. "Ground truth" is established by the specifications of the standards themselves (e.g., ISO 3964 requires a specific coupling dimension, ISO 10993 outlines biocompatibility criteria). Expertise would lie with engineers and biocompatibility specialists performing and interpreting the tests, ensuring compliance with the specified standards.

4. Adjudication Method for the Test Set:

Not applicable. Performance is measured objectively against quantitative and qualitative criteria defined by the standards (e.g., a dimension either meets ISO 3964 or it doesn't; a material either passes cytotoxicity or it doesn't). There is no "adjudication" in the sense of expert consensus on an interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for diagnostic imaging devices, especially those involving AI, where human readers interpret medical images. The OK Handpiece is a mechanical dental tool, not an imaging or diagnostic device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

No, a standalone algorithm performance study was not done. This device does not incorporate any algorithms or AI for standalone performance evaluation.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is based on engineering specifications and compliance with established international consensus standards (e.g., ISO for mechanical properties, ISO for biocompatibility, ISO/ANSI/AAMI for sterilization). For example, the "ground truth" for motor coupling is adherence to the dimensions specified in ISO 3964.

8. The Sample Size for the Training Set:

Not applicable. This device is a mechanical medical instrument. It does not utilize machine learning or AI, and therefore has no "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set for an algorithm, there is no ground truth to establish for it.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, featuring a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the full name "U.S. FOOD & DRUG ADMINISTRATION" written in blue text.

July 15, 2022

Jaintek Co.,Ltd % Dave Yungvirt Most Responsible Person Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

Re: K221814

Trade/Device Name: OK Handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental handpiece and accessories Regulatory Class: Class I, reserved Product Code: EFB Dated: June 16, 2022 Received: June 22, 2022

Dear Dave Yungvirt:

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.

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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) 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 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.

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) K221814

Device Name Trade Name: OK 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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510(k) Summary

K221814

SUBMITTER INFORMATION 1.

Manufacturer:	JAINTECK CO., LTD.
	#302, 419, Byeolmang-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Republic of Korea
Contact Person:	Jung Gun Lee / Representative
	Tel) +82-31-495-9091
	Fax) +82-31-495-9092
	Email) jain98@naver.com
Date Prepared:	May 5, 2022

2. DEVICE INFORMATION

Trade Name:	OK Handpiece
Model Number:	OKH4
Common Name:	Reciprocating Contra Angle Handpiece
Product Code:	EFB
Regulation Number:	21 CFR 872.4200
Class:	1

3. PREDICATE DEVICE INFORMATION

K082827 (A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE Predicate Device: HANDPIECE ATTACHMENT, WA-67A)

Reference Device: K150750 (Contra-Angle Handpieces, ENDO 6:1)

4. DESCRIPTION OF THE DEVICE

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motion in the head.

The OK handpiece is a reprocessing medical device. Users must steam sterilize before each use, and clean thoroughly after use.

The OK handpiece does not have water/air spray and light supply. Therefore, the air motor connection of the handpiece is designed to comply with the coupling size of TYPE 1 of ISO 3964. For the strip connecting to the OK handpiece, you must use Orthok-Strips and OK Proxofile of Jaintek Co., Ltd.

INDICATION FOR USE 5.

TECHNICLOGICAL CHARACTERISTICS 6.

	Subject Device	Predicate Device 1	Predicate Device 2	Remark
510(k) Number	TBD	K082827	K150750	-
Proprietary Name	OK Handpiece(Model#: OKH4)	A-DEC/W&HPROFINRECIPROCATINGCONTRA-ANGLEHANDPIECEATTACHMENT	Contra-AngleHandpieces	-
Model Number	OKH4	WA-67A	ENDO 6:1	-
Manufacturer	JAINTECK CO.,LTD.	A-DEC, INC.	Sirona DentalSystems GMBH	-
Regulatory Class	Class I	Class I	Class I	Same
RegulationNumber	21 CFR 872.4200	21 CFR 872.4200	21 CFR 872.4200	Same
Product Code	EFB	EFB	EGS	Same
Indication forUse	A dental contra-angle handpiecethat attaching averticalreciprocatingdentalendpiece(strips)intended to beused ininterproximalreduction of teeth;And it is part oforthodontic	The A-dec/W&HSynea Profinreciprocating contra-angle handpieceattachment isintended for use inremoving protrusionsor excess of fillingmaterials andcements,preparation, finishingand polishing in theinterdental and	The contra-anglehandpieces are usedto hold and driveburr instruments forthe purposes ofrotary processing.The handpieces areintended for dentalapplications inendodontics and forroot canalmeasurement andare used by trained	Similar

	treatment offinishinginterdental andsubgingival area,finishing cavityedges, removingthe dentin of teethadjacent, removingsubgingival plagueand tripping. Thedeviceincorporates asmall micro motornormally driven bycompressed air;This is a reusabledevice.	subgingival regions,stripping, vibrating ofinlays usingDentatus tips androot canalpreparations usingendodontic files.	dental personnel indental practices andlaboratories. The T1Spray is intended tobe used to clean andlubricate dentalhandpieces.
Handpiece Type	Contra-anglehandpiece	Contra-anglehandpiece	Contra-anglehandpiece	Same
Movement ofconnected strips	Verticalreciprocating	Vertical reciprocating	Rotation	Same
Composition ofmaterial	Stainless Still	Stainless Still	Stainless Still	Same
Motor Coupling	ISO 3964Compliance	ISO 3964Compliance	ISO 3964Compliance	Same
Air/Water spray	Not applicable	Water spray	Not applicable	Same
Bur Extractionforce	$22N \le$	Unknown	Unknown	Different
Light (Fiberoptics)	Not applicable	Not applicable	Not applicable	Same
Max rotationspeed	10,000 rpm	20,000 rpm	40,000 rpm	Different
Type of chuck	Sliding chuck	Sliding chuck	Push Button	Same
Sterilization	Steam sterilization	Steam sterilization	Steam sterilization	Same
Lubricant	PANS SPRAYPLUS(K163483)	Oil F1, MD-400(K162926)	T1 Spray(K150750)	-

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The subject device has the same Indication for use, Operation mode, No fiberoptics, type of chuck, coupling dimensions, conformance with standards for shanks, No hose connection, movement of connected strips, sterilization method, and reuse life as predicate device 1.

Predicate device 1 has a water spray function, but subject device does not have a water spray function. However, since the predicate device 2 also does not have a water spray function, the presence or absence of the water jet function does not affect safety and effectiveness.

Since the bur extraction force of the predicates devices is unknown, it is not possible to compare

510(K) SUMMARY

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them equivalence. But, since the extraction force of the subject device satisfies the requirements of ISO 14457, safety and effectiveness are not affected.

The subject device, predicate device 1, and predicate device 2 have different RPM ranges. However, since the RPM range of the target device is within the RPM range of the preceding device, safety or effectiveness is not affected.

An accurate comparison of the raw materials for human contact between the subject and predicate devices cannot be made due to lack of information. However, since the suitability of the raw material has been verified through biocompatibility evaluation, it does not cause any problems with safety or effectiveness.

7. SUMMARY OF NON-CLINICAL DATA

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:

() Bench Test

The subject device is complied with the following performance standards:

ISO 3964 Third edition 11-2016, Dentistry Coupling dimensions for handpiece connectors ●
ISO 14457 Second edition 2017-10, Dentistry - Handpieces and motors

O Biocompatibility

The subject device is manufactured from 304 stainless steel, which has been evaluated for the following biocompatibility in accordance with ISO 10993-1:2018.

ISO 10993-5:2009 (In vitro Cytotoxicity)
ISO 10993-10:2010 (Skin Sensitization) ●
ISO 10993-10:2010 (Oral mucosa irritation)

O Sterilization

The subject device is provided non-sterile. The end user must sterilize according to the recommended parameters (Pre-vacuum, 135 degrees/3 minutes sterilization, 30 minutes drying) using an autoclave before use. In this sterilization parameter, the subject device meets Sterility Assurance Level of 1E-6 and has been verified according to the standards below.

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
ISO/TS 17665-2:2009, Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1
ISO 11138-1:2017, Sterilization of health care products - Biological indicators - Part 1: General requirements
ISO 11737-1:2018, Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities

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10. SUMMARY OF CLINICAL DATA

Clinical Data was not required to demonstrate the substantial equivalence.

11. CONCLUSION

OK Handpiece is manufactured from biocompatible raw materials. In addition, it has the similar indication for use, the same design characteristics, and similar performance as the predicate device. And the substantial equivalence of the subject device was confirmed through a non-clinical testing. Therefore, the OK Handpiece has been proven to be equivalent to a 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.