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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cement, dental
510(k) Number K121804
Device Name PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM
Original Applicant
ITENA CLINICAL
500 boul cartier west
laval,  CA h7v 5b7
Original Contact louis paul marin
Regulation Number872.3275
Classification Product Code
EMA  
Date Received06/19/2012
Decision Date 04/19/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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