FDA 510(k) Application Details - K232827

Device Classification Name	Bracket, Ceramic, Orthodontic   More FDA Info for this Device
510(K) Number	K232827
Device Name	Bracket, Ceramic, Orthodontic
Applicant	LightForce Orthodontics 44 Third Ave Burlington, MA 01803 US Other 510(k) Applications for this Company
Contact	Jeffrey Roberts 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	09/13/2023
Decision Date	09/14/2023
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