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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 K931475
Device Name ARGELITE 55
Original Applicant
8380 miralani dr.
san diego,  CA  92126
Original Contact manohar malhotra
Regulation Number872.3060
Classification Product Code
Date Received03/24/1993
Decision Date 07/08/1993
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No