FDA 510(k) Application Details - K200214

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K200214
Device Name	Aligner, Sequential
Applicant	3D Smile USA, Inc 3675 Market Street Suite #200 Philadelphia, PA 19104 US Other 510(k) Applications for this Company
Contact	Marina Domracheva 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	01/28/2020
Decision Date	02/24/2020
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	Y
Expedited Review