Cleared Traditional

AURIUM 68M

K952402 · Argen Precious Metals, Inc. · Dental
Jun 1995
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K952402 is an FDA 510(k) clearance for the AURIUM 68M, 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 June 16, 1995, 25 days after receiving the submission on May 22, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K952402 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 1995
Decision Date June 16, 1995
Days to Decision 25 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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