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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 K122551
Device Name PROVITEMP
Applicant
Itena Clinical
500 Boul Cartier W.
Laval,  CA H7V 5B7
Applicant Contact LOUIS-PAUL MARIN
Correspondent
Itena Clinical
500 Boul Cartier W.
Laval,  CA H7V 5B7
Correspondent Contact LOUIS-PAUL MARIN
Regulation Number872.3275
Classification Product Code
EMA  
Date Received08/21/2012
Decision Date 06/14/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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