RAYDENT SW is an AI-enabled medical device from RAY Co., Ltd., listed by FDA (510(k), K233625) with a decision date of 2024-05-16. Review panel: Dental.
| FDA submission number | K233625 |
|---|---|
| Pathway | 510(k) |
| Company | RAY Co., Ltd. |
| Review panel (specialty) | Dental |
| FDA decision date | 2024-05-16 |
| Decision | Substantially Equivalent |
| Product code | PNN |
| Classification | Orthodontic Software |
| Device class | 2 |
| Regulation number | 872.5470 |
| Review time (calendar days) | 185 |
| Applicant country | KR |
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.