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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 K122549
Device Name DENTO TEMP
Applicant
ITENA CLINICAL
500 boul cartier west
laval, 
Contact louis-paul marin
Regulation Number872.3275
Classification Product Code
EMA  
Date Received08/21/2012
Decision Date 04/26/2013
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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