Cleared Traditional

SURGICAL HANDPIECES, MIKRO SAW HANDPIECES

K080939 · W&H Dentalwerk Buermoos GmbH · Dental
Jul 2008
Decision
117d
Days
Class 2
Risk

About This 510(k) Submission

K080939 is an FDA 510(k) clearance for the SURGICAL HANDPIECES, MIKRO SAW HANDPIECES, a Handpiece, Rotary Bone Cutting (Class II — Special Controls, product code KMW), submitted by W&H Dentalwerk Buermoos GmbH (Buermoos, AT). The FDA issued a Cleared decision on July 29, 2008, 117 days after receiving the submission on April 3, 2008. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K080939 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2008
Decision Date July 29, 2008
Days to Decision 117 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KMW — Handpiece, Rotary Bone Cutting
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4120