FDA.reportPublic FDA data

BRIUS Technologies Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30146809243014680924BRIUS Technologies Inc.1N2026-01-012611 Westgrove Drive Carrollton TX US 75006

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2194171656646834K202792BRIUS Clear AlignersNXC2021-01-22
2194171432700513K191720BRUIS Software SuitePNN2020-04-17
2194171692948116

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NXC12021-01-22
PNN12020-04-17

PMN#

GUDID#

Brius Planner - BRIUS Planner is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, treatment simulation and virtual appliance design options (Patient-Specific Nitinol Wires, Sequential Aligners, Export of Models, Indirect Bonding Transfer Media) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. The use of the BRIUS Planner requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

Brius Technologies Inc

2026-06-05