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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 K092251
Device Name BIODENTINE
Applicant
Septodont
1050 Connecticut Ave., NW
Washington,  DC  20036
Applicant Contact WAYNE MATELSKI
Correspondent
Septodont
1050 Connecticut Ave., NW
Washington,  DC  20036
Correspondent Contact WAYNE MATELSKI
Regulation Number872.3820
Classification Product Code
KIF  
Subsequent Product Code
EJK  
Date Received07/28/2009
Decision Date 10/30/2009
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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