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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Metal, Base
510(k) Number K935972
Device Name ARGELOY N.P. (V) (NON-PRECIOUS DENTAL ALLOY FOR PROCELAIN APPLICATION)
Applicant
Argen Precious Metals, Inc.
8380 Miralani Dr.
San Diego,  CA  92126
Applicant Contact DR. MANOHAR LAL MALHOTRA
Correspondent
Argen Precious Metals, Inc.
8380 Miralani Dr.
San Diego,  CA  92126
Correspondent Contact DR. MANOHAR LAL MALHOTRA
Regulation Number872.3710
Classification Product Code
EJH  
Date Received12/13/1993
Decision Date 01/26/1994
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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