FDA 510(k) Application Details - K193357

Device Classification Name	Cleanser, Root Canal   More FDA Info for this Device
510(K) Number	K193357
Device Name	Cleanser, Root Canal
Applicant	Inter-Med/ Vista Dental Products 2220 South Street Suite A Racine, WI 53404 US Other 510(k) Applications for this Company
Contact	Katherine Barry 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	12/04/2019
Decision Date	10/23/2020
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