Cleared Traditional

Electric Handpiece Motor

K181858 · W&H Dentalwerk Buermoos GmbH · Dental
Mar 2019
Decision
257d
Days
Class 1
Risk

About This 510(k) Submission

K181858 is an FDA 510(k) clearance for the Electric Handpiece Motor, a Controller, Foot, Handpiece And Cord (Class I — General Controls, product code EBW), submitted by W&H Dentalwerk Buermoos GmbH (Burmoos, AT). The FDA issued a Cleared decision on March 26, 2019, 257 days after receiving the submission on July 12, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K181858 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 2018
Decision Date March 26, 2019
Days to Decision 257 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBW — Controller, Foot, Handpiece And Cord
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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