FDA 510(k) Application Details - K193385

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K193385
Device Name	Aligner, Sequential
Applicant	TP Orthodontics Inc. 100 Center Plaza La Porte, IN 46350-9672 US Other 510(k) Applications for this Company
Contact	Stephanie Thyen Other 510(k) Applications for this Contact
Regulation Number	872.5470   More FDA Info for this Regulation Number
Classification Product Code	NXC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/06/2019
Decision Date	11/12/2020
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