FDA 510(k) Application Details - K173876

Device Classification Name	Activator, Ultraviolet, For Polymerization   More FDA Info for this Device
510(K) Number	K173876
Device Name	Activator, Ultraviolet, For Polymerization
Applicant	DXM Co., Ltd Baekseok-dong, Ilsan technotown 1003, 138, Ilsan-ro, Ilsandong-gu Goyang-si 411-360 KR Other 510(k) Applications for this Company
Contact	Seung Hyun Kim 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	12/21/2017
Decision Date	01/24/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review