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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 K121769
Device Name DENTOCORE / DENTOCORE BODY
Applicant
ITENA CLINICAL
500 BOUL CARTIER WEST
LAVAL,  CA H7V 5B7
Applicant Contact LOUIS- PAUL MARIN
Correspondent
ITENA CLINICAL
500 BOUL CARTIER WEST
LAVAL,  CA H7V 5B7
Correspondent Contact LOUIS- PAUL MARIN
Regulation Number872.3690
Classification Product Code
EBF  
Date Received06/15/2012
Decision Date 03/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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