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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 K972937
Device Name AURECAST 4
Applicant
Aurex Precious Metal Industries (Pty)Ltd
P.O. Box 509
Edenvale,  ZA 1610
Applicant Contact J.D. DAVIS
Correspondent
Aurex Precious Metal Industries (Pty)Ltd
P.O. Box 509
Edenvale,  ZA 1610
Correspondent Contact J.D. DAVIS
Regulation Number872.3060
Classification Product Code
EJT  
Date Received06/20/1997
Decision Date 08/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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