Cleared Traditional

285 SL

K961352 · Argen Precious Metals, Inc. · Dental
May 1996
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K961352 is an FDA 510(k) clearance for the 285 SL, 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 May 20, 1996, 42 days after receiving the submission on April 8, 1996. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K961352 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 1996
Decision Date May 20, 1996
Days to Decision 42 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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