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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 K090644
Device Name VITABLOCS, MODEL VX55-****
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  
Date Received03/10/2009
Decision Date 03/31/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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