FDA 510(k) Application Details - K171844

Device Classification Name	Bracket, Ceramic, Orthodontic   More FDA Info for this Device
510(K) Number	K171844
Device Name	Bracket, Ceramic, Orthodontic
Applicant	Ormco Corporation 1717 W. Collins Avenue Orange, CA 92867 US Other 510(k) Applications for this Company
Contact	Tara Bonny 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	06/20/2017
Decision Date	07/18/2017
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