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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K070991
Device Name VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-4310
Applicant
Vita
3150 E. Birch St.
Brea,  CA  92821
Applicant Contact ELIZABETH WOLFSEN
Correspondent
Vita
3150 E. Birch St.
Brea,  CA  92821
Correspondent Contact ELIZABETH WOLFSEN
Regulation Number872.3770
Classification Product Code
EBG  
Date Received04/09/2007
Decision Date 06/01/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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