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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Root Canal Filling
510(k) Number K140132
Device Name BIODENTINE
Applicant
Septodont
416 S. Taylor Ave.
Louisville,  CO  80027
Applicant Contact CORA BRACHO-TROCONIS
Correspondent
Septodont
416 S. Taylor Ave.
Louisville,  CO  80027
Correspondent Contact CORA BRACHO-TROCONIS
Regulation Number872.3820
Classification Product Code
KIF  
Subsequent Product Code
EMA  
Date Received01/17/2014
Decision Date 06/27/2014
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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