FDA 510(k) Application Details - K143212

Device Classification Name	Cement, Dental   More FDA Info for this Device
510(K) Number	K143212
Device Name	Cement, Dental
Applicant	VOCO GMBH Anto-Flettner-Str. 1-3 Cuxhaven 27472 DE Other 510(k) Applications for this Company
Contact	M. Th. Plaumann 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	11/10/2014
Decision Date	05/01/2015
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