FDA 510(k) Application Details - K140846

Device Classification Name	Cleanser, Root Canal   More FDA Info for this Device
510(K) Number	K140846
Device Name	Cleanser, Root Canal
Applicant	ESSENTIAL DENTAL SYSTEMS, INC. 89 LEUNING STREET SUITE 8 SOUTH HACKENSACK, NJ 07606 US Other 510(k) Applications for this Company
Contact	JEFFREY WAN 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	04/03/2014
Decision Date	07/25/2014
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