FDA 510(k) Application Details - K210763

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K210763
Device Name	Aligner, Sequential
Applicant	Inman Orthodontic Laboratories, Inc. 3953 NW 126th Avenue Coral Springs, FL 33065 US Other 510(k) Applications for this Company
Contact	Donal P. Inman 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	03/15/2021
Decision Date	09/29/2021
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