FDA 510(k) Application Details - K042196

Device Classification Name	Activator, Ultraviolet, For Polymerization   More FDA Info for this Device
510(K) Number	K042196
Device Name	Activator, Ultraviolet, For Polymerization
Applicant	DENFOTEX LIGHT SYSTEMS LTD UNIT 15, BELLEKNOWES IND.EST INVERKEITHING FIFE, SCOTLAND KY11 1H7 GB Other 510(k) Applications for this Company
Contact	JOHN COLLES 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	08/13/2004
Decision Date	11/01/2004
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	Y
Expedited Review