FDA 510(k) Application Details - K083901

Device Classification Name	Locator, Root Apex   More FDA Info for this Device
510(K) Number	K083901
Device Name	Locator, Root Apex
Applicant	S-DENTI CO., LTD. 5401 S COTTONWOOD CT GREENWOOD VILLAGE, CO 80121 US Other 510(k) Applications for this Company
Contact	Kevin Walls Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/29/2008
Decision Date	04/15/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review