FDA 510(k) Application Details - K232011

Device Classification Name	Bracket, Ceramic, Orthodontic   More FDA Info for this Device
510(K) Number	K232011
Device Name	Bracket, Ceramic, Orthodontic
Applicant	American Orthodontics 3524 Washington Avenue Sheboygan, WI 53081 US Other 510(k) Applications for this Company
Contact	Laura Richmond 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	07/06/2023
Decision Date	07/07/2023
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