FDA 510(k) Application Details - K060946

Device Classification Name	Resin, Root Canal Filling   More FDA Info for this Device
510(K) Number	K060946
Device Name	Resin, Root Canal Filling
Applicant	PARKELL, INC. 300 EXECUTIVE DR. EDGEWOOD, NY 11717 US Other 510(k) Applications for this Company
Contact	NELSON J GENDUSA 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	04/06/2006
Decision Date	06/15/2006
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