FDA 510(k) Application Details - K122753

Device Classification Name	Bracket, Ceramic, Orthodontic   More FDA Info for this Device
510(K) Number	K122753
Device Name	Bracket, Ceramic, Orthodontic
Applicant	AMERICAN ORTHODONTICS 1536 N. 18TH ST. SHEBOYGAN, WI 53081 US Other 510(k) Applications for this Company
Contact	TRANG ADAMS 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	09/07/2012
Decision Date	12/14/2012
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