(23 days)
No
The document describes a mechanical dental handpiece and does not mention any AI or ML components or functionalities.
No.
The device is used for mechanical procedures like interproximal reduction, finishing, and plaque removal, not for treating a disease or disorder.
No
Explanation: The device is described as a dental contra-angle handpiece used for interproximal reduction of teeth, finishing, and removing debris. Its function is to perform mechanical modifications to teeth, not to diagnose a condition or disease.
No
The device is a physical contra-angle handpiece that attaches to an air motor and uses reciprocating motion for dental procedures. It is described as a reusable, reprocessing medical device requiring sterilization, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a dental handpiece used for mechanical procedures on teeth and surrounding tissues (interproximal reduction, finishing, removing material). It directly interacts with the patient's anatomy.
- Lack of Specimen Analysis: The device does not analyze any biological specimens. Its function is purely mechanical.
The description clearly indicates a dental tool used for physical manipulation of teeth and surrounding areas, which falls under the category of a surgical or dental instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
EFB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth, interdental and subgingival area, cavity edges
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental personnel in dental practices and laboratories
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)
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
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)
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
Clinical Data was not required to demonstrate the substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
Indications for Use
510(k) Number (if known) K221814
Device Name Trade Name: OK Handpiece
Indications for Use (Describe)
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.
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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3
510(k) Summary
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
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
4
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.
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.
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&H | |||
| PROFIN | ||||
| RECIPROCATING | ||||
| CONTRA-ANGLE | ||||
| HANDPIECE | ||||
| ATTACHMENT | Contra-Angle | |||
| Handpieces | - | |||
| Model Number | OKH4 | WA-67A | ENDO 6:1 | - |
| Manufacturer | JAINTECK CO., | |||
| LTD. | A-DEC, INC. | Sirona Dental | ||
| Systems GMBH | - | |||
| Regulatory Class | Class I | Class I | Class I | Same |
| Regulation | ||||
| Number | 21 CFR 872.4200 | 21 CFR 872.4200 | 21 CFR 872.4200 | Same |
| Product Code | EFB | EFB | EGS | Same |
| Indication for | ||||
| Use | A dental contra-angle handpiece | |||
| that attaching a | ||||
| vertical | ||||
| reciprocating | ||||
| dental | ||||
| endpiece(strips) | ||||
| intended to be | ||||
| used in | ||||
| interproximal | ||||
| reduction of teeth; | ||||
| And it is part of | ||||
| orthodontic | The A-dec/W&H | |||
| Synea Profin | ||||
| reciprocating contra-angle handpiece | ||||
| attachment is | ||||
| intended for use in | ||||
| removing protrusions | ||||
| or excess of filling | ||||
| materials and | ||||
| cements, | ||||
| preparation, finishing | ||||
| and polishing in the | ||||
| interdental and | The contra-angle | |||
| handpieces are used | ||||
| to hold and drive | ||||
| burr instruments for | ||||
| the purposes of | ||||
| rotary processing. | ||||
| The handpieces are | ||||
| intended for dental | ||||
| applications in | ||||
| endodontics and for | ||||
| root canal | ||||
| measurement and | ||||
| are used by trained | Similar | |||
| 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. | subgingival regions, | |||
| stripping, vibrating of | ||||
| inlays using | ||||
| Dentatus tips and | ||||
| root canal | ||||
| preparations using | ||||
| endodontic files. | dental personnel in | |||
| dental practices and | ||||
| laboratories. The T1 | ||||
| Spray is intended to | ||||
| be used to clean and | ||||
| lubricate dental | ||||
| handpieces. | ||||
| Handpiece Type | Contra-angle | |||
| handpiece | Contra-angle | |||
| handpiece | Contra-angle | |||
| handpiece | Same | |||
| Movement of | ||||
| connected strips | Vertical | |||
| reciprocating | Vertical reciprocating | Rotation | Same | |
| Composition of | ||||
| material | Stainless Still | Stainless Still | Stainless Still | Same |
| Motor Coupling | ISO 3964 | |||
| Compliance | ISO 3964 | |||
| Compliance | ISO 3964 | |||
| Compliance | Same | |||
| Air/Water spray | Not applicable | Water spray | Not applicable | Same |
| Bur Extraction | ||||
| force | $22N \le$ | Unknown | Unknown | Different |
| Light (Fiber | ||||
| optics) | Not applicable | Not applicable | Not applicable | Same |
| Max rotation | ||||
| speed | 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 SPRAY | |||
| PLUS | ||||
| (K163483) | Oil F1, MD-400 | |||
| (K162926) | T1 Spray | |||
| (K150750) | - |
5
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
6
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
7
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.