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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Gold-Based Noble Metal
510(k) Number K892909
Device Name ARGELITE 80SF+ DENTAL ALLOY
Applicant
Argen Precious Metals, Inc.
8380 Miralani Dr.
San Diego,  CA  92126
Applicant Contact LAL MALHOTRA
Correspondent
Argen Precious Metals, Inc.
8380 Miralani Dr.
San Diego,  CA  92126
Correspondent Contact LAL MALHOTRA
Regulation Number872.3060
Classification Product Code
EJT  
Date Received04/20/1989
Decision Date 05/22/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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