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FDA 510(k)

Air-Powered Handpieces and Handpiece Attachments

K-Number: K162926 · 2017-02-23

ApplicantW&H Dentalwerk Burmoos GmbH
Decision Date2017-02-23
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Air-Powered Handpieces and Handpiece Attachments is a medical device manufactured by W&H Dentalwerk Burmoos GmbH. It received FDA 510(k) clearance on 2017-02-23 under approval number K162926. 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 Air-Powered Handpieces and Handpiece Attachments?

Air-Powered Handpieces and Handpiece Attachments is a medical device that received FDA 510(k) clearance on 2017-02-23. It is manufactured by W&H Dentalwerk Burmoos GmbH. The 510(k) number is K162926.

When was Air-Powered Handpieces and Handpiece Attachments approved by the FDA?

Air-Powered Handpieces and Handpiece Attachments received FDA 510(k) clearance on 2017-02-23, under approval number K162926.

What company makes Air-Powered Handpieces and Handpiece Attachments?

Air-Powered Handpieces and Handpiece Attachments is manufactured by W&H Dentalwerk Burmoos GmbH.

What is the FDA product code for Air-Powered Handpieces and Handpiece Attachments?

The FDA product code for Air-Powered Handpieces and Handpiece Attachments is EFB.

Other Devices by W&H Dentalwerk Burmoos GmbH

K161957W&H Implantmed SI-1015 incl. Accessories

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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