FDA 510(k) Application Details - K160551

Device Classification Name	Activator, Ultraviolet, For Polymerization   More FDA Info for this Device
510(K) Number	K160551
Device Name	Activator, Ultraviolet, For Polymerization
Applicant	ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH SOUTH JORDAN, UT 84095 US Other 510(k) Applications for this Company
Contact	Marie Hess 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	02/29/2016
Decision Date	07/13/2016
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