Cleared Traditional

ARGENCO 68M

K954361 · Argen Precious Metals, Inc. · Dental
Oct 1995
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K954361 is an FDA 510(k) clearance for the ARGENCO 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 October 7, 1995, 19 days after receiving the submission on September 18, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K954361 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 1995
Decision Date October 07, 1995
Days to Decision 19 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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