Cleared Traditional

SUREFIRE PF+ (HIGH PALLADIUM DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS)

K950894 · Argen Precious Metals, Inc. · Dental

Mar 1995

Decision

32d

Days

Class 2

Risk

About This 510(k) Submission

K950894 is an FDA 510(k) clearance for the SUREFIRE PF+ (HIGH PALLADIUM DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS), a Alloy, Metal, Base (Class II — Special Controls, product code EJH), submitted by Argen Precious Metals, Inc. (San Diego, US). The FDA issued a Cleared decision on March 31, 1995, 32 days after receiving the submission on February 27, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.3710.

Submission Details

510(k) Number	K950894 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 27, 1995
Decision Date	March 31, 1995
Days to Decision	32 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement