Cleared Traditional

AUROLITE 55

K950858 · Argen Precious Metals, Inc. · Dental
Mar 1995
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K950858 is an FDA 510(k) clearance for the AUROLITE 55, 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 March 16, 1995, 17 days after receiving the submission on February 27, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K950858 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 1995
Decision Date March 16, 1995
Days to Decision 17 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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