FDA 510(k) Application Details - K214054

Device Classification Name	Adhesive, Bracket And Tooth Conditioner, Resin   More FDA Info for this Device
510(K) Number	K214054
Device Name	Adhesive, Bracket And Tooth Conditioner, Resin
Applicant	TP Orthodontics, Inc. 100 Center Plaza La Porte, IN 46350-9672 US Other 510(k) Applications for this Company
Contact	Cristiane Muller Other 510(k) Applications for this Contact
Regulation Number	872.3750   More FDA Info for this Regulation Number
Classification Product Code	DYH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/27/2021
Decision Date	10/14/2022
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