Cleared Traditional

K952403 - AUROLITE 80
(FDA 510(k) Clearance)

K952403 · Argen Precious Metals, Inc. · Dental

Jun 1995

Decision

30d

Days

Class 2

Risk

K952403 is an FDA 510(k) clearance for the AUROLITE 80, 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 June 21, 1995, 30 days after receiving the submission on May 22, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number	K952403 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 22, 1995
Decision Date	June 21, 1995
Days to Decision	30 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement