FDA 510(k) Application Details - K090925

Device Classification Name	Locator, Root Apex   More FDA Info for this Device
510(K) Number	K090925
Device Name	Locator, Root Apex
Applicant	J. MORITA USA, INC. 1425 K STREET NW SUITE 1100 WASHINGTON, DC 20005 US Other 510(k) Applications for this Company
Contact	KEITH A BARRITT 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	04/02/2009
Decision Date	11/23/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review