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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 K132070
Device Name VITA SUPRINITY(R)
Applicant
Vita Zahnfabrik H.Rauter GmbH & Co.
3150 E. Birch St.
Brea,  CA  92821
Applicant Contact NEVINE ERIAN
Correspondent
Vita Zahnfabrik H.Rauter GmbH & Co.
3150 E. Birch St.
Brea,  CA  92821
Correspondent Contact NEVINE ERIAN
Regulation Number872.6660
Classification Product Code
EIH  
Date Received07/03/2013
Decision Date 01/31/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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