OK Handpiece

FDA 510(k) K221814 · Jaintek Co.,Ltd

Substantially Equivalent

510(k) numberK221814

Submission

Device name
OK Handpiece
Applicant
Jaintek Co.,Ltd
Ansan-Si, KR
Received
June 22, 2022
Decision date
July 15, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
EFB – Handpiece, Air-Powered, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.4200
Specialty
Dental

Other 510(k)s with product code EFB

510(k)DeviceApplicantDecision
K251389High speed air turbine handpieceEFB · Traditional Foshan Topmed Dental Co., Ltd.01/12/2026SE
K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES…EFB · Traditional Foshan Topmed Dental Co., Ltd.01/12/2026SE
K242179Synea Fusion Handpieces (Intensiv & Profin)EFB · Traditional W&H Dentalwerk Bürmoos GmbH02/28/2025SE
K240337Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)EFB · Traditional Guangdong Jinme Medical Technology Co., Ltd.11/13/2024SE
K241074High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low…EFB · Traditional Foshan Soco Precision Instrument Co., Ltd.11/12/2024SE
K241880Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System…EFB · Traditional Nakanishi, Inc.09/20/2024SE
K233122High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800…EFB · Traditional Litu Tech , Ltd.04/30/2024SE
K233308Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)EFB · Traditional Nakanishi, Inc.04/25/2024SE
K220179High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air MotorsEFB · Traditional Foshan Coxo Medical Instrument Co., Ltd.09/22/2023SE
K232243EVO 700 series high speed handpieceEFB · Special Ttbio Corp.08/23/2023SE

Questions and answers

When was OK Handpiece cleared by the FDA?

OK Handpiece (K221814) received a 510(k) decision of Substantially Equivalent on July 15, 2022, 23 days after the submission was received.

What is the product code of K221814?

The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.