De Novo Classifications
FDA submissions for De Novo Classifications in the Dental (DE) review panel, including product codes, regulations, and recent device decisions.
Section range: §§ 872.5590–872.5595
CFR Part: 872
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| QUA | Intraoral Cooling Device | 872.5590 | 2 | 2 |
| SGQ | Intraoral Phototherapy Device | 872.5595 | 2 | 1 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| DEN240077 | MuReva OM | Mureva Phototherapy, Inc. | Nov 26, 2025 |
| K232917 | Chemo Mouthpiece | Chemo Mouthpiece, LLC | Jan 23, 2024 |
| DEN210027 | The Cooral System | Braincool AB | Oct 14, 2022 |
