FDA 510(k) Application Details - K221097

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K221097
Device Name	Aligner, Sequential
Applicant	Ordont Orthodontic Laboratories, Inc. 1755 Smizer Station Road Fenton, MO 63026 US Other 510(k) Applications for this Company
Contact	Paul Rudzicka 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	04/14/2022
Decision Date	07/14/2022
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