Cleared Traditional

ARGEDENT 40(GOLD-PALLADIUM-SILVER ALLOY FOR PORCELAIN APPLICATION)

K961285 · Argen Precious Metals, Inc. · Dental

Apr 1996

Decision

15d

Days

Class 2

Risk

About This 510(k) Submission

K961285 is an FDA 510(k) clearance for the ARGEDENT 40(GOLD-PALLADIUM-SILVER ALLOY FOR PORCELAIN APPLICATION), 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 April 18, 1996, 15 days after receiving the submission on April 3, 1996. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number	K961285 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 03, 1996
Decision Date	April 18, 1996
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement