TRIOS Dx (R1) is an AI-enabled medical device from 3Shape TRIOS A/S, listed by FDA (510(k), K260082) with a decision date of 2026-04-10. Review panel: Dental.
| FDA submission number | K260082 |
|---|---|
| Pathway | 510(k) |
| Company | 3Shape TRIOS A/S |
| Review panel (specialty) | Dental |
| FDA decision date | 2026-04-10 |
| Decision | Substantially Equivalent |
| Product code | SHQ |
| Classification | Dental Image Analyzer, In-Office |
| Device class | 2 |
| Regulation number | 872.1770 |
| Review time (calendar days) | 88 |
| Applicant country | DK |
Official FDA database record · FDA AI-enabled device list
All Dental AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.