FDA 510(k) Application Details - K221475

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K221475
Device Name	Aligner, Sequential
Applicant	Key Dental Technologies, LLC 920 MLK Blvd Suite 920-B Chapel Hill, NC 27517 US Other 510(k) Applications for this Company
Contact	Larry Moray 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	05/20/2022
Decision Date	08/31/2022
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