FDA 510(k) Application Details - K061689

Device Classification Name	Cleanser, Root Canal   More FDA Info for this Device
510(K) Number	K061689
Device Name	Cleanser, Root Canal
Applicant	PURICORE, INC. 320 KING OF PRUSSIA ROAD SUITE 200 RADNOR, PA 19087 US Other 510(k) Applications for this Company
Contact	HOWARD MANN Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	KJJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/15/2006
Decision Date	08/24/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review