FDA 510(k) Application Details - K042769

Device Classification Name	Resin, Root Canal Filling   More FDA Info for this Device
510(K) Number	K042769
Device Name	Resin, Root Canal Filling
Applicant	META BIOMED CO., LTD. 41-19, 77TH STREET ELMHURST, NY 11373 US Other 510(k) Applications for this Company
Contact	JENNY SHON 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	10/05/2004
Decision Date	11/24/2004
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	Y
Expedited Review