FDA 510(k) Application Details - K191806

Device Classification Name	Locator, Root Apex   More FDA Info for this Device
510(K) Number	K191806
Device Name	Locator, Root Apex
Applicant	Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401 US Other 510(k) Applications for this Company
Contact	Karl Nittinger Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/05/2019
Decision Date	10/03/2019
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