FDA 510(k) Application Details - K101054

Device Classification Name	Locator, Root Apex   More FDA Info for this Device
510(K) Number	K101054
Device Name	Locator, Root Apex
Applicant	ROMIDAN LTD 5 SIMCHA HOLZBERG ST. KIRYAT-ONO 55022 IL Other 510(k) Applications for this Company
Contact	EITAN MARGALIT 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	04/15/2010
Decision Date	09/03/2010
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