Cleared Traditional

GOLD DENTAL CASTING ALLOYS

K033279 · Bego U.S.A. · Dental
Jan 2004
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K033279 is an FDA 510(k) clearance for the GOLD DENTAL CASTING ALLOYS, a Alloy, Gold-based Noble Metal (Class II — Special Controls, product code EJT), submitted by Bego U.S.A. (Lincoln, US). The FDA issued a Cleared decision on January 15, 2004, 97 days after receiving the submission on October 10, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K033279 FDA.gov
FDA Decision Cleared SESE
Date Received October 10, 2003
Decision Date January 15, 2004
Days to Decision 97 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJT — Alloy, Gold-based Noble Metal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3060

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