FDA 510(k) Application Details - K080749

Device Classification Name	Bracket, Ceramic, Orthodontic   More FDA Info for this Device
510(K) Number	K080749
Device Name	Bracket, Ceramic, Orthodontic
Applicant	AMERICAN ORTHODONTICS 1714 CAMBRIDGE AVE. SHEBOYGAN, WI 53081 US Other 510(k) Applications for this Company
Contact	JEROME H SCHOMBERG 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	03/17/2008
Decision Date	08/04/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review