FDA 510(k) Application Details - K123538

Device Classification Name	Cleanser, Root Canal   More FDA Info for this Device
510(K) Number	K123538
Device Name	Cleanser, Root Canal
Applicant	EPIEN MEDICAL, INC. 700 THIRTEENTH ST. NW STUITE 200 WASHINGTON, DC 20005 US Other 510(k) Applications for this Company
Contact	JEFFREY K SHAPIRO 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	11/16/2012
Decision Date	02/01/2013
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