Cleared Traditional

V-SUPRAGOLD, ALLOY NO. 5024

K993507 · Metalor Dental USA Corp. · Dental
Dec 1999
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K993507 is an FDA 510(k) clearance for the V-SUPRAGOLD, ALLOY NO. 5024, a Alloy, Gold-based Noble Metal (Class II — Special Controls, product code EJT), submitted by Metalor Dental USA Corp. (North Attleborough, US). The FDA issued a Cleared decision on December 6, 1999, 52 days after receiving the submission on October 15, 1999. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K993507 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 1999
Decision Date December 06, 1999
Days to Decision 52 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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