FDA 510(k) Application Details - K213916

Device Classification Name	More FDA Info for this Device
510(K) Number	K213916
Device Name	ArchForm Orthodontic Software System
Applicant	ArchForm, Inc 8421 Blue Heron Drive Bakersfield, CA 93312 US Other 510(k) Applications for this Company
Contact	Andrew S. Martz Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2021
Decision Date	12/16/2021
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	Y
Expedited Review