Cleared Traditional

ARGESOL 750PY

K943208 · Argen Precious Metals, Inc. · Dental
Aug 1994
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K943208 is an FDA 510(k) clearance for the ARGESOL 750PY, 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 August 1, 1994, 27 days after receiving the submission on July 5, 1994. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K943208 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 1994
Decision Date August 01, 1994
Days to Decision 27 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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