Cleared Traditional

SOLDER AUROLITE CB

K943755 · Argen Precious Metals, Inc. · Dental
Sep 1994
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K943755 is an FDA 510(k) clearance for the SOLDER AUROLITE CB, 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 September 9, 1994, 38 days after receiving the submission on August 2, 1994. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K943755 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 1994
Decision Date September 09, 1994
Days to Decision 38 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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