FDA 510(k) Application Details - K230225

Device Classification Name	Bracket, Ceramic, Orthodontic   More FDA Info for this Device
510(K) Number	K230225
Device Name	Bracket, Ceramic, Orthodontic
Applicant	Dyna Flex 8050 Hawk Ridge Trail Lake Saint Louis, MO 63367 US Other 510(k) Applications for this Company
Contact	Matthew Malabey 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	01/27/2023
Decision Date	06/05/2023
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	N
Expedited Review