3 devices · 3 companies · 2018 to 2026
Product code PNN: Orthodontic Software
3 devices under product code PNN, 2018 to 2026, from 3 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (3 of 3 here), the regulation, and MAUDE report counts by product code.
Orthodontic Software. 21 CFR 872.5470, Class II. The device is software that is to be used for the diagnosis and treatment planning of orthodontic patients and conditions. It may include orthodontic output devices used for the treatment of orthodontics. The device is intended for prescription use only. MAUDE held 1 adverse-event report against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| LingOral Dental Design SystemK260419 · 510(k) | Hangzhou ChohoTech Co., Ltd. | Dental | database entry | |
| RAYDENT SWK233625 · 510(k) | RAY Co., Ltd. | Dental | database entry | |
| CEREC Ortho SoftwareK171122 · 510(k) | Dentsply Sirona | Dental | database entry |
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