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FDA 510(k)

Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece

K-Number: K212910 · 2022-11-17

ApplicantShenzhen Carejoy Technology Co., Ltd.
Decision Date2022-11-17
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece is a medical device manufactured by Shenzhen Carejoy Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-11-17 under approval number K212910. 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 Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece?

Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece is a medical device that received FDA 510(k) clearance on 2022-11-17. It is manufactured by Shenzhen Carejoy Technology Co., Ltd.. The 510(k) number is K212910.

When was Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece approved by the FDA?

Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece received FDA 510(k) clearance on 2022-11-17, under approval number K212910.

What company makes Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece?

Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece is manufactured by Shenzhen Carejoy Technology Co., Ltd..

What is the FDA product code for Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece?

The FDA product code for Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece is EFB.

Related Devices (Code: EFB)

K160410WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small headDental Savings Club K153411430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed HandpieceDentalez, Inc. K151912AIR-FLOW handy 3.0 PLUSE.M.S Electro Medical Systems S.A K171174PERIO-FLOW nozzleE.M.S Electro Medical Systems S.A K171553W&H Assistina TwinW&H Dentalwerk Buermoos GmbH K170236Dental Low-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd.

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.

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