FDA 510(k) Application Details - K172164

Device Classification Name	Driver, Wire, And Bone Drill, Manual   More FDA Info for this Device
510(K) Number	K172164
Device Name	Driver, Wire, And Bone Drill, Manual
Applicant	Propel Orthodontics LLC 394 South Abbott Ave Milpitas, CA 95035 US Other 510(k) Applications for this Company
Contact	Bryce Way Other 510(k) Applications for this Contact
Regulation Number	872.4120   More FDA Info for this Regulation Number
Classification Product Code	DZJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/18/2017
Decision Date	01/17/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review