7 devices · 7 companies · 2018 to 2026
AI-enabled dental devices on FDA's list
7 devices in the Dental panel, 2018 to 2026, from 7 companies across 5 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (7 of 7 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes in the Dental panel
Every device, newest decision first
| Decision | Device | Company | Product code | FDA |
|---|---|---|---|---|
| LingOral Dental Design SystemK260419 · 510(k) | Hangzhou ChohoTech Co., Ltd. | PNN | database entry | |
| TRIOS DxK260082 · 510(k) | 3Shape TRIOS A/S | SHQ | database entry | |
| DentalMonitoringDEN230035 · De Novo | Dental Monitoring SAS | SBC | database entry | |
| RAYDENT SWK233625 · 510(k) | RAY Co., Ltd. | PNN | database entry | |
| X-Guide Surgical Navigation SystemK232148 · 510(k) | X-Nav Technologies, LLC | QRY | database entry | |
| MATRx plusDEN170090 · De Novo | Zephyr Sleep Technologies | QCJ | database entry | |
| CEREC Ortho SoftwareK171122 · 510(k) | Dentsply Sirona | PNN | database entry |
Every panel in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.