FDA 510(k) Application Details - K093208

Device Classification Name	Resin, Root Canal Filling   More FDA Info for this Device
510(K) Number	K093208
Device Name	Resin, Root Canal Filling
Applicant	DISCUS DENTAL, LLC 8550 HIGUERA ST. CULVER CITY, CA 90232 US Other 510(k) Applications for this Company
Contact	CLARK D VONAHSEN 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	10/13/2009
Decision Date	02/12/2010
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