LingOral Dental Design System is an AI-enabled medical device from Hangzhou ChohoTech Co., Ltd. that the U.S. FDA cleared through 510(k) K260419 on May 8, 2026. Its lead review panel is Dental and its primary product code is PNN (Orthodontic Software).
See also all FDA AI clearances in 2026.
Key facts
| Submission number | K260419 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Hangzhou ChohoTech Co., Ltd. |
| Lead review panel | Dental |
| Primary product code | PNN — Orthodontic Software |
| Applicant (openFDA) | Hangzhou ChohoTech Co., Ltd. |
| Applicant location | Hangzhou, CN |
| Device class | Class 2 |
| Regulation number | 21 CFR 872.5470 |
| 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. LingOral Dental Design System went through this pathway (K260419).
openFDA lists it as a Class 2 device under 21 CFR 872.5470. Class II devices are moderate risk and are subject to general and special controls.
Product code PNN covers 3 devices on the FDA AI list. By decision date, this device is #3 of 3 under that code. Hangzhou ChohoTech Co., Ltd. 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.