Decision Date2022-07-15
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
OK Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Jaintek Co.,Ltd. It received FDA 510(k) clearance on 2022-07-15 under 510(k) number K221814. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OK Handpiece?
OK Handpiece is a medical device that received FDA 510(k) clearance on 2022-07-15. The listed applicant is Jaintek Co.,Ltd. The 510(k) number is K221814.
When did OK Handpiece receive FDA 510(k) clearance?
OK Handpiece received FDA 510(k) clearance on 2022-07-15, under 510(k) number K221814.
Who is the listed applicant for OK Handpiece?
The FDA 510(k) record lists Jaintek Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OK Handpiece?
The FDA product code for OK Handpiece is EFB.
Related Devices (Code: EFB)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
K251389High speed air turbine handpieceFoshan Topmed Dental Co., Ltd.K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)Foshan Topmed Dental Co., Ltd.K242179Synea Fusion Handpieces (Intensiv & Profin)W&H Dentalwerk Bürmoos GmbHK240337Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)Guangdong Jinme Medical Technology Co., Ltd.K241074High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)Foshan Soco Precision Instrument Co., Ltd.K241880Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)Nakanishi, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.