Cleared Abbreviated

BEGOPAL+

K123929 · Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO · Dental
Mar 2013
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K123929 is an FDA 510(k) clearance for the BEGOPAL+, a Alloy, Metal, Base (Class II — Special Controls, product code EJH), submitted by Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO (Bremen, DE). The FDA issued a Cleared decision on March 14, 2013, 84 days after receiving the submission on December 20, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.3710.

Submission Details

510(k) Number K123929 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2012
Decision Date March 14, 2013
Days to Decision 84 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EJH — Alloy, Metal, Base
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3710