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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 K001482
Device Name AURENORM 75 KF
Applicant
Aurex SA (Pty) , Ltd.
24 Plantation Rd., Eastleigh
Edenvale, Gauteng,  ZA 1610
Applicant Contact J. D DAVIS
Correspondent
Aurex SA (Pty) , Ltd.
24 Plantation Rd., Eastleigh
Edenvale, Gauteng,  ZA 1610
Correspondent Contact J. D DAVIS
Regulation Number872.3060
Classification Product Code
EJT  
Date Received05/11/2000
Decision Date 06/23/2000
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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