FDA 510(k) Application Details - K060347

Device Classification Name	Plugger, Root Canal, Endodontic   More FDA Info for this Device
510(K) Number	K060347
Device Name	Plugger, Root Canal, Endodontic
Applicant	B&L BIOTECH CO., LTD. PO BOX 7007 DEERFIELD, IL 60015 US Other 510(k) Applications for this Company
Contact	DANIEL KAMM Other 510(k) Applications for this Contact
Regulation Number	872.4565   More FDA Info for this Regulation Number
Classification Product Code	EKR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/10/2006
Decision Date	06/05/2006
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