Cleared Traditional

BEGOPAL

K983078 · Bego U.S.A. · Dental
Oct 1998
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K983078 is an FDA 510(k) clearance for the BEGOPAL, a Alloy, Other Noble Metal (Class II — Special Controls, product code EJS), submitted by Bego U.S.A. (Pawtucket, US). The FDA issued a Cleared decision on October 23, 1998, 51 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 K983078 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 1998
Decision Date October 23, 1998
Days to Decision 51 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