Cleared Traditional

MEISINGER BENEX, MODEL BE001

K062130 · Hager& Meisinger GmbH · Dental
Apr 2007
Decision
264d
Days
Class 1
Risk

About This 510(k) Submission

K062130 is an FDA 510(k) clearance for the MEISINGER BENEX, MODEL BE001, a Forceps, Tooth Extractor, Surgical (Class I — General Controls, product code EMG), submitted by Hager& Meisinger GmbH (Centennial, US). The FDA issued a Cleared decision on April 16, 2007, 264 days after receiving the submission on July 26, 2006. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K062130 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2006
Decision Date April 16, 2007
Days to Decision 264 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EMG — Forceps, Tooth Extractor, Surgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565

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