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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sealant, Pit And Fissure, And Conditioner
510(k) Number K110058
Device Name BPA-FREE PIT AND FISSURE SEALANT
Applicant
Novocol Inc. Dba Septodont and Confi-Dental Produc
416 S. Taylor Ave.
Louisville,  CO  80027
Applicant Contact CORA BRACHO-TROCONIS
Correspondent
Novocol Inc. Dba Septodont and Confi-Dental Produc
416 S. Taylor Ave.
Louisville,  CO  80027
Correspondent Contact CORA BRACHO-TROCONIS
Regulation Number872.3765
Classification Product Code
EBC  
Date Received01/10/2011
Decision Date 03/31/2011
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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