FDA 510(k) Application Details - K160957

Device Classification Name	Bracket, Ceramic, Orthodontic   More FDA Info for this Device
510(K) Number	K160957
Device Name	Bracket, Ceramic, Orthodontic
Applicant	CDB CORPORATION 9201 INDUSTRIAL BOULEVARD, NE LELAND, NC 28451 US Other 510(k) Applications for this Company
Contact	YANNIRE THOMPSON 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	04/05/2016
Decision Date	09/27/2016
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