FDA 510(k) Application Details - K212828

Device Classification Name	More FDA Info for this Device
510(K) Number	K212828
Device Name	BRIUS Planner Software
Applicant	BRIUS Technologies Inc 2611 Westgrove Dr Carrollton, TX 75006 US Other 510(k) Applications for this Company
Contact	Mehdi Roein-Peiker 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	09/03/2021
Decision Date	10/01/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review