FDA 510(k) Application Details - K130163

Device Classification Name	Activator, Ultraviolet, For Polymerization   More FDA Info for this Device
510(K) Number	K130163
Device Name	Activator, Ultraviolet, For Polymerization
Applicant	DIADENT GROUP INTERNATIONAL 626, YEONJE-RI, GANGOE-MYEON CHEONGWON-GUN CHUNGCHEONG BUK-DO 363-951 KR Other 510(k) Applications for this Company
Contact	GIL JUN, HONG 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	01/23/2013
Decision Date	08/16/2013
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	Y
Expedited Review