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FDA 510(k)

WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head

K-Number: K160410 · 2016-09-29

ApplicantDental Savings Club
Decision Date2016-09-29
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head is a medical device manufactured by Dental Savings Club. It received FDA 510(k) clearance on 2016-09-29 under approval number K160410. 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 WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head?

WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head is a medical device that received FDA 510(k) clearance on 2016-09-29. It is manufactured by Dental Savings Club. The 510(k) number is K160410.

When was WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head approved by the FDA?

WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head received FDA 510(k) clearance on 2016-09-29, under approval number K160410.

What company makes WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head?

WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head is manufactured by Dental Savings Club.

What is the FDA product code for WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head?

The FDA product code for WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head is EFB.

Related Clinical Trials

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Related PubMed Literature

PMID: 27660042 A medical device-grade T1 and ECV phantom for global T1 mapping quality assurance-the T Journal of cardiovascular magnetic resonance : official journal of the Society for Cardiovascular Magnetic Resonance (2016)

Related Devices (Code: EFB)

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. K170229Dental High-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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