FDA 510(k) Application Details - K201785

Device Classification Name	Cleanser, Root Canal   More FDA Info for this Device
510(K) Number	K201785
Device Name	Cleanser, Root Canal
Applicant	EPIEN Medical, Inc. 4225 White Bear Parkway Suite 600 St. Paul, MN 55110 US Other 510(k) Applications for this Company
Contact	Reginald Dupre 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	06/30/2020
Decision Date	09/09/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review