FDA 510(k) Application Details - K153018

Device Classification Name	Activator, Ultraviolet, For Polymerization   More FDA Info for this Device
510(K) Number	K153018
Device Name	Activator, Ultraviolet, For Polymerization
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	872.6070   More FDA Info for this Regulation Number
Classification Product Code	EBZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/15/2015
Decision Date	06/23/2016
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