FDA 510(k) Application Details - K250343

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K250343
Device Name	Aligner, Sequential
Applicant	LuxCreo Inc. 350 W. Ontario Street Suite 700 Chicago, IL 60654 US Other 510(k) Applications for this Company
Contact	Tao Feng 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	02/06/2025
Decision Date	04/08/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review