FDA 510(k) Application Details - K070401

Device Classification Name	Cleanser, Root Canal   More FDA Info for this Device
510(K) Number	K070401
Device Name	Cleanser, Root Canal
Applicant	ESSENTIAL DENTAL SYSTEMS, INC. 55 NORTHERN BLVD., SUITE 200 GREAT NECK, NY 11021 US Other 510(k) Applications for this Company
Contact	SUSAN GOLDSTEIN-FALK 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	02/12/2007
Decision Date	07/11/2007
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