TRIOS Dx (R1) is an AI-enabled medical device from 3Shape TRIOS A/S that the U.S. FDA cleared through 510(k) K260082 on April 10, 2026. Its lead review panel is Dental and its primary product code is SHQ (Dental Image Analyzer, In-Office).
See also all FDA AI clearances in 2026.
Key facts
| Submission number | K260082 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | 3Shape TRIOS A/S |
| Lead review panel | Dental |
| Primary product code | SHQ — Dental Image Analyzer, In-Office |
| Applicant (openFDA) | 3Shape TRIOS A/S |
| Applicant location | Copenhagen, DK |
| Device class | Class 2 |
| Regulation number | 21 CFR 872.1770 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. TRIOS Dx (R1) went through this pathway (K260082).
openFDA lists it as a Class 2 device under 21 CFR 872.1770. Class II devices are moderate risk and are subject to general and special controls.
Product code SHQ covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. 3Shape TRIOS A/S has 1 AI-enabled device on the list, and the Dental panel accounts for 7 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.