Facility
BRIUS Technologies Inc.
1 recall(s) on record — most severe on record: Class II.
| FDA Establishment Identifier (FEI) | 3014680924 |
|---|---|
| Establishment type | Manufacture Medical Device |
| Location | 2611 Westgrove Drive Carrollton, TX, US 75006 |
| Registration status | Active · expires 2026 |
| Parent company | Brius (owner-operator 10057851) |
| Brand names | Brius Software |
Devices registered here (1)
- Orthodontic SoftwareProduct code PNN · Class II · Dental · 21 CFR 872.5470
Recalls & enforcement
- Class IITerminated2022-02-07Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.
Related
Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-13. Verify this facility record at FDA →
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