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FDA 510(k) Application Details - K122551
Device Classification Name
Cement, Dental
More FDA Info for this Device
510(K) Number
K122551
Device Name
Cement, Dental
Applicant
ITENA CLINICAL
500 BOUL CARTIER WEST
LAVAL H7V 5B7 CA
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Contact
LOUIS-PAUL MARIN
Other 510(k) Applications for this Contact
Regulation Number
872.3275
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Classification Product Code
EMA
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More FDA Info for this Product Code
Date Received
08/21/2012
Decision Date
06/14/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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