FDA 510(k) Application Details - K200908

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K200908
Device Name	Aligner, Sequential
Applicant	3D Diagnostix Inc. 24 Denby Road Allston, MA 02134 US Other 510(k) Applications for this Company
Contact	Ehab Amin 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	04/06/2020
Decision Date	12/22/2020
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