FDA 510(k) Application Details - K163117

Device Classification Name	Bracket, Ceramic, Orthodontic   More FDA Info for this Device
510(K) Number	K163117
Device Name	Bracket, Ceramic, Orthodontic
Applicant	KOROAD AMERICA 895 DOVE ST, SUITE 300 NEWPORT BEACH, CA 92660 US Other 510(k) Applications for this Company
Contact	YEON JAE LEE Other 510(k) Applications for this Contact
Regulation Number	872.5470   More FDA Info for this Regulation Number
Classification Product Code	NJM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/07/2016
Decision Date	05/09/2017
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	N
Expedited Review