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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K122269
Device Name ENAMIC
Applicant
VITA ZAHNFABRIK H. RAUTER GMBH & CO.
3150 EAST BIRCH STREET
BREA,  CA  92821
Applicant Contact ELIZABETH WOLFSEN
Correspondent
VITA ZAHNFABRIK H. RAUTER GMBH & CO.
3150 EAST BIRCH STREET
BREA,  CA  92821
Correspondent Contact ELIZABETH WOLFSEN
Regulation Number872.6660
Classification Product Code
EIH  
Subsequent Product Code
EBF  
Date Received07/30/2012
Decision Date 12/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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