FDA 510(k) Application Details - K202792

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K202792
Device Name	Aligner, Sequential
Applicant	Brius Technologies, Inc 2611 Westgrove Dr Ste 109 Carrollton, TX 75006 US Other 510(k) Applications for this Company
Contact	Kate Garrett 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	09/22/2020
Decision Date	01/22/2021
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