Cleared Abbreviated

CONTRA-ANGLE HANDPIECE KOMET OS30

K090548 · W&H Dentalwerk Buermoos GmbH · Dental
Jun 2009
Decision
120d
Days
Class 1
Risk

About This 510(k) Submission

K090548 is an FDA 510(k) clearance for the CONTRA-ANGLE HANDPIECE KOMET OS30, a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by W&H Dentalwerk Buermoos GmbH (Buermoos, AT). The FDA issued a Cleared decision on June 30, 2009, 120 days after receiving the submission on March 2, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K090548 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2009
Decision Date June 30, 2009
Days to Decision 120 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EFB — Handpiece, Air-powered, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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