FDA 510(k) Application Details - K162311

Device Classification Name	Cleanser, Root Canal   More FDA Info for this Device
510(K) Number	K162311
Device Name	Cleanser, Root Canal
Applicant	INSTITUT STRAUMANN AG PETER MERIAN WEG 12 BASEL CH-4002 CH Other 510(k) Applications for this Company
Contact	CHRISTOPHER KLACZYK 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	08/18/2016
Decision Date	03/07/2017
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