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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 K102128
Device Name VITABLOCS
Applicant
Vita Zahnfabrik H.Rauter GmbH & Co.
3150 E. Birch St.
Brea,  CA  92821
Applicant Contact ELIZABETH WOLFSEN
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number872.6660
Classification Product Code
EIH  
Date Received07/29/2010
Decision Date 08/11/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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