Manufacturer registered with FDA
Brius
Carrollton, TX, United States. Lists 3 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 22021–2021
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Devices listed with FDA
What Brius currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | Brava | 2018 |
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | BRIUS Aligner | 2021 |
| Orthodontic SoftwarePNN · Class 2 | Dental design & orthodontic software | Maker | Brius Software | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Brius lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Mechanodontics, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 17 Apr 2020 | K191720 | BRUIS Software Suite | Mechanodontics, Inc. | PNN Orthodontic Software |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BRIUS Technologies Inc.FDA reg. 3014680924 | Carrollton, TX, United States | Manufacturer |
Other names on FDA records
Brius Technologies, Inc.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10057851). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.