FDA 510(k) Application Details - K091362

Device Classification Name	Crown, Preformed   More FDA Info for this Device
510(K) Number	K091362
Device Name	Crown, Preformed
Applicant	EZ-PEDO INC 2350 PROFESSIONAL DRIVE SUITE 200 ROSEVILLE, CA 95661 US Other 510(k) Applications for this Company
Contact	JEFFREY FISHER Other 510(k) Applications for this Contact
Regulation Number	872.3330   More FDA Info for this Regulation Number
Classification Product Code	ELZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/08/2009
Decision Date	06/29/2009
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