Cleared Traditional

ARGELITE 61 (PALLADIUM - SILVER DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS)

K950772 · Argen Precious Metals, Inc. · Dental

Mar 1995

Decision

20d

Days

Class 2

Risk

About This 510(k) Submission

K950772 is an FDA 510(k) clearance for the ARGELITE 61 (PALLADIUM - SILVER DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS), 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 13, 1995, 20 days after receiving the submission on February 21, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number	K950772 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 21, 1995
Decision Date	March 13, 1995
Days to Decision	20 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement