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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 E. Birch St.
Brea,  CA  92821
Applicant Contact ELIZABETH WOLFSEN
Correspondent
Vita Zahnfabrik H.Rauter GmbH & Co.
3150 E. Birch St.
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
Predetermined Change
Control Plan Authorized		 No
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