FDA 510(k) Application Details - K121621

Device Classification Name	Cement, Dental   More FDA Info for this Device
510(K) Number	K121621
Device Name	Cement, Dental
Applicant	COLTENE/WHALEDENT AG FELDWIESENSTRASSE 20 ALTSTATTEN CH-9450 CH Other 510(k) Applications for this Company
Contact	SILKE WALLASCHEK 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	06/01/2012
Decision Date	01/08/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review