Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Brius Technologies, Inc. with 3 device recalls and 2 510(k) clearances. The most recent is a device recall dated Feb 7, 2022: Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Feb 7, 2022 | Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device,Class II · Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard desi | Device recalls |
| Feb 7, 2022 | Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400ULClass II · Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard desi | Device recalls |
| Feb 7, 2022 | Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400ULClass II · Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard desi | Device recalls |
| Oct 1, 2021 | BRIUS Planner SoftwareK212828 · PNN | 510(k) clearances |
| Jan 22, 2021 | BRIUS Clear AlignersK202792 · NXC | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
