De Novo Classifications
FDA submissions for De Novo Classifications in the Dental (DE) review panel, including product codes and regulations.
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 |