FDA 510(k) Application Details - K163689

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K163689
Device Name	Aligner, Sequential
Applicant	3M Unitek Corporation 2724 South Peck Road Monrovia, CA 91016 US Other 510(k) Applications for this Company
Contact	Yanine Garcia-Quezada Other 510(k) Applications for this Contact
Regulation Number	872.5470   More FDA Info for this Regulation Number
Classification Product Code	NXC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/28/2016
Decision Date	01/27/2017
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	Y
Expedited Review