FDA 510(k) Application Details - K192233

Device Classification Name	Activator, Ultraviolet, For Polymerization   More FDA Info for this Device
510(K) Number	K192233
Device Name	Activator, Ultraviolet, For Polymerization
Applicant	Foshan CICADA Dental Instrument Co., Ltd. B5-2F, Guangdong New Light Source Industrial Base Shihan Town, Nanhai Foshan CN Other 510(k) Applications for this Company
Contact	Juan Liu 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	08/19/2019
Decision Date	02/13/2020
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	N
Expedited Review