FDA 510(k) Application Details - K110756

Device Classification Name	Activator, Ultraviolet, For Polymerization   More FDA Info for this Device
510(K) Number	K110756
Device Name	Activator, Ultraviolet, For Polymerization
Applicant	IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. AMHERST, NY 14228 US Other 510(k) Applications for this Company
Contact	DONNA MARIE HARTNETT 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	03/18/2011
Decision Date	08/29/2011
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