Cleared Traditional

BEGOPAL 300

K983081 · Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO · Dental
Oct 1998
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K983081 is an FDA 510(k) clearance for the BEGOPAL 300, a Alloy, Other Noble Metal (Class II — Special Controls, product code EJS), submitted by Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO (Bremen, DE). The FDA issued a Cleared decision on October 28, 1998, 56 days after receiving the submission on September 2, 1998. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K983081 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 1998
Decision Date October 28, 1998
Days to Decision 56 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJS — Alloy, Other Noble Metal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3060