FDA 510(k) Application Details - K032662

Device Classification Name	Resin, Root Canal Filling   More FDA Info for this Device
510(K) Number	K032662
Device Name	Resin, Root Canal Filling
Applicant	COLTENE/WHALEDENT GMBH & CO. KG 235 ASCOT PARKWAY CUYAHOGA FALLS, OH 44223 US Other 510(k) Applications for this Company
Contact	HENRY J VOGELSTEIN Other 510(k) Applications for this Contact
Regulation Number	872.3820   More FDA Info for this Regulation Number
Classification Product Code	KIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/28/2003
Decision Date	11/03/2003
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