Cleared Traditional

PROSTHODONTIC SCREWDRIVER , MODEL IA-400

K100600 · W&H Dentalwerk Buermoos GmbH · Dental
Jul 2010
Decision
128d
Days
Class 1
Risk

About This 510(k) Submission

K100600 is an FDA 510(k) clearance for the PROSTHODONTIC SCREWDRIVER , MODEL IA-400, a Handpiece, Direct Drive, Ac-powered (Class I — General Controls, product code EKX), submitted by W&H Dentalwerk Buermoos GmbH (Buermoos, AT). The FDA issued a Cleared decision on July 9, 2010, 128 days after receiving the submission on March 3, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K100600 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 2010
Decision Date July 09, 2010
Days to Decision 128 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EKX — Handpiece, Direct Drive, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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