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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K101540
Device Name GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE
Applicant
Novocol Inc. Dba Septodont and Confi-Dental Produc
416 S. Taylor Ave.
Louisville,  CO  80027
Applicant Contact STEVE RUDOLPH
Correspondent
Novocol Inc. Dba Septodont and Confi-Dental Produc
416 S. Taylor Ave.
Louisville,  CO  80027
Correspondent Contact STEVE RUDOLPH
Regulation Number872.3690
Classification Product Code
EBF  
Date Received06/03/2010
Decision Date 10/29/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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