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FDA 510(k)

Dental Air Polishing Handpiece

K-Number: K221548 · 2022-09-28

ApplicantGuilin Woodpecker Medical Instrument Co., Ltd.
Decision Date2022-09-28
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental Air Polishing Handpiece is a medical device manufactured by Guilin Woodpecker Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2022-09-28 under approval number K221548. 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 Air Polishing Handpiece?

Dental Air Polishing Handpiece is a medical device that received FDA 510(k) clearance on 2022-09-28. It is manufactured by Guilin Woodpecker Medical Instrument Co., Ltd.. The 510(k) number is K221548.

When was Dental Air Polishing Handpiece approved by the FDA?

Dental Air Polishing Handpiece received FDA 510(k) clearance on 2022-09-28, under approval number K221548.

What company makes Dental Air Polishing Handpiece?

Dental Air Polishing Handpiece is manufactured by Guilin Woodpecker Medical Instrument Co., Ltd..

What is the FDA product code for Dental Air Polishing Handpiece?

The FDA product code for Dental Air Polishing Handpiece is EFB.

Related Clinical Trials

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Other Devices by Guilin Woodpecker Medical Instrument Co., Ltd.

K181087Apex Locator, DPEX III K211531Cordless Prophy System, Model: i-Polish K203615Dental Scaler and Air Polisher K212080Imaging Plate Scanner, i-Scan K203320Endo Motor K222569Ai Ray Dental X-Ray Device

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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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