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FDA 510(k)

Electric Handpiece Motor

K-Number: K181858 · 2019-03-26

ApplicantW&H Dentalwerk Buermoos GmbH
Decision Date2019-03-26
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Electric Handpiece Motor is a medical device manufactured by W&H Dentalwerk Buermoos GmbH. It received FDA 510(k) clearance on 2019-03-26 under approval number K181858. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Electric Handpiece Motor?

Electric Handpiece Motor is a medical device that received FDA 510(k) clearance on 2019-03-26. It is manufactured by W&H Dentalwerk Buermoos GmbH. The 510(k) number is K181858.

When was Electric Handpiece Motor approved by the FDA?

Electric Handpiece Motor received FDA 510(k) clearance on 2019-03-26, under approval number K181858.

What company makes Electric Handpiece Motor?

Electric Handpiece Motor is manufactured by W&H Dentalwerk Buermoos GmbH.

What is the FDA product code for Electric Handpiece Motor?

The FDA product code for Electric Handpiece Motor is EBW.

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Other Devices by W&H Dentalwerk Buermoos GmbH

K171553W&H Assistina Twin K201703PROXEO Twist Cordless Polishing System PL-40 H K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)

Related Devices (Code: EBW)

K161957W&H Implantmed SI-1015 incl. AccessoriesW&H Dentalwerk Burmoos GmbH K163402NLZ Motor SystemNakanishi, Inc. K163131A-dec NLZ Electric Motor SystemNakanishi, Inc. K163317ELECTROmaticKaltenbach & Voigt Gmgh K161213XSmart iQDentsply Sirona K173905Surgic Pro, Surgic Pro+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.

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