QUA
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Intraoral Cooling Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.5590
- Medical specialty
- Dental
- FDA definition
- An intraoral cooling device is a prescription use device that is intended to cool the mouth for patients at risk for oral mucositis. An intraoral cooling device consists of a removable mouthpiece and accessories that cool oral mucosal surfaces
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Chemo Mouthpiece (K232917) | Chemo Mouthpiece, LLC | 2024-01-23 |
| The Cooral System (DEN210027) | Braincool AB | 2022-10-14 |
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Every clearance here is in the API, with alerts when new ones post.