FDA 510(k) Application Details - K063812

Device Classification Name	Cleanser, Root Canal   More FDA Info for this Device
510(K) Number	K063812
Device Name	Cleanser, Root Canal
Applicant	STRAUMANN USA 60 MINUTETEMAN ROAD ANDOVER, MA 01810 US Other 510(k) Applications for this Company
Contact	LISA M QUAGLIA Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	KJJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2006
Decision Date	01/12/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review