Data / Medical devices / United States / BRIUS Technologies Inc.
BRIUS Technologies Inc.: FDA-registered device maker in Carrollton, TX, United States, 2 510(k) clearances
BRIUS Technologies Inc. is registered with the FDA (registration 3014680924) in Carrollton, TX, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 22, 2021. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014680924
- Address
- 2611 Westgrove Drive, Carrollton, TX, United States, 75006
- Owner or operator
- Brius (10057851)
- Roles
- Manufacturer
- First device listed
- June 4, 2018
- Registered through
- 2026
- Brand names listed
- BRIUS Aligner, Brava, Brius Software
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aligner, Sequential | NXC | 2 | Manufacturer | accessdata.fda.gov |
| Orthodontic Software | PNN | 2 | Manufacturer | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 22, 2021 | K202792 | BRIUS Clear Aligners | NXC | Substantially Equivalent | Brius Technologies, Inc. | accessdata.fda.gov |
| April 17, 2020 | K191720 | BRUIS Software Suite | PNN | Substantially Equivalent | Mechanodontics, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 7, 2022 | 89569 | Class II | Terminated | Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS, RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL | Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released. | accessdata.fda.gov |
Compare with other makers
Updated January 22, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.