FDA 510(k) Application Details - K212680

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K212680
Device Name	Aligner, Sequential
Applicant	Luxcreo Inc 940 Old County Road, Belmont, CA 94002 US Other 510(k) Applications for this Company
Contact	Mike Yang 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	08/24/2021
Decision Date	05/31/2022
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