Brius Technologies Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 2
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0888-2022 | Class II | Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-Sterile | February 7, 2022 |
| Z-0889-2022 | Class II | Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , R | February 7, 2022 |
| Z-0890-2022 | Class II | Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom | February 7, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K212828 | BRIUS Planner Software | October 1, 2021 |
| K202792 | BRIUS Clear Aligners | January 22, 2021 |