FDA 510(k) Application Details - K163605

Device Classification Name	Activator, Ultraviolet, For Polymerization   More FDA Info for this Device
510(K) Number	K163605
Device Name	Activator, Ultraviolet, For Polymerization
Applicant	DENTMATE TECHNOLOGY CO., LTD. 8F, No.8-11, Sec.1, Zhongxing Road, Wugu District New Taipei 24872 TW Other 510(k) Applications for this Company
Contact	CHENG-FENG CHOU 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	12/21/2016
Decision Date	01/19/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review