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
Other 510(k) Applications for this Company
Contact LOUIS-PAUL MARIN
Other 510(k) Applications for this Contact
Regulation Number 872.3275

  More FDA Info for this Regulation Number
Classification Product Code EMA
Other 510(k) Applications for this Device

  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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact