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FDA 510(k) Application Details - K122521
Device Classification Name
Sealant, Pit And Fissure, And Conditioner
More FDA Info for this Device
510(K) Number
K122521
Device Name
Sealant, Pit And Fissure, And Conditioner
Applicant
ITENA CLINICAL
500 BOUL CARTIER WEST
LAVAL H7V 5B7 CA
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Contact
LOUIS-PAUL MARIN
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Regulation Number
872.3765
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Classification Product Code
EBC
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More FDA Info for this Product Code
Date Received
08/20/2012
Decision Date
06/11/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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