Cleared Traditional

AUROLITE 45

K954404 · Argen Precious Metals, Inc. · Dental
Oct 1995
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K954404 is an FDA 510(k) clearance for the AUROLITE 45, a Alloy, Gold-based Noble Metal (Class II — Special Controls, product code EJT), submitted by Argen Precious Metals, Inc. (San Diego, US). The FDA issued a Cleared decision on October 7, 1995, 17 days after receiving the submission on September 20, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K954404 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 1995
Decision Date October 07, 1995
Days to Decision 17 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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