FDA 510(k) Application Details - K233935

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K233935
Device Name	Aligner, Sequential
Applicant	Park Dental Research Corporation 2401 N. Commerce Street Suite E Ardmore, OK 73401 US Other 510(k) Applications for this Company
Contact	Logan Simmons 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	12/14/2023
Decision Date	04/05/2024
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