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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 K891519
Device Name C-86 GOLD BASE DENTAL ALLOY
Original Applicant
MACDONALD METALS AND CERAMICS
13519 1/2 alondra blvd.
santa fe springs,  CA  90670
Original Contact ronald a macdonald
Regulation Number872.3060
Classification Product Code
EJT  
Date Received03/17/1989
Decision Date 04/12/1989
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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