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

Alloy, Gold-based Noble Metal

ARGEN PRECIOUS METALS, INC.

The following data is part of a premarket notification filed by Argen Precious Metals, Inc. with the FDA for Argelite 61 (palladium - Silver Dental Casting Alloy For Porcelain Applications).

Pre-market Notification Details

Device IDK950772
510k NumberK950772
Device Name:ARGELITE 61 (PALLADIUM - SILVER DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS)
ClassificationAlloy, Gold-based Noble Metal
Applicant ARGEN PRECIOUS METALS, INC. 8380 MIRALANI DR. San Diego,  CA  92126
ContactManohar L Malhortra
CorrespondentManohar L Malhortra
ARGEN PRECIOUS METALS, INC. 8380 MIRALANI DR. San Diego,  CA  92126
Product CodeEJT  
CFR Regulation Number872.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-02-21
Decision Date1995-03-13

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