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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 the device name listed in this FDA 510(k) record. The listed applicant is W&H Dentalwerk Buermoos GmbH. It received FDA 510(k) clearance on 2019-03-26 under 510(k) 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. The listed applicant is W&H Dentalwerk Buermoos GmbH. The 510(k) number is K181858.

When did Electric Handpiece Motor receive FDA 510(k) clearance?

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

Who is the listed applicant for Electric Handpiece Motor?

The FDA 510(k) record lists W&H Dentalwerk Buermoos GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electric Handpiece Motor?

The FDA product code for Electric Handpiece Motor is EBW.

Other records listing W&H Dentalwerk Buermoos GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253776Implantmed Plus II & Piezomed Plus II ModuleK243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)K201703PROXEO Twist Cordless Polishing System PL-40 HK171553W&H Assistina Twin

Related Devices (Code: EBW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251407Motor Handpiece and Control Unit (SDI10)Saeshin Precision Co., Ltd.K251701Star E900 Electric SystemDentalez, Inc., Stardental DivisionK251811Motor and Apex Module (MaAM)Dentsply Sirona, Inc.K231562ELEC ENGINE (Model: ISE-170L)Micro-Nx Co., Ltd.K242646Dental Implant UnitGuilin Aesthedent Medical Instruments Co., Ltd.K233288NLZ Built-In Motor SystemNakanishi, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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