Product code QUA
- Device name
- Intraoral Cooling Device
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.5590
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K232917 | Chemo Mouthpiece | Chemo Mouthpiece, LLC | 2024-01-23 |
| DEN210027 | The Cooral System | Braincool AB | 2022-10-14 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 20860001416743 | Chemo Mouthpiece | CHEMOMOUTHPIECE, LLC | 2024-05-23 |
| 20860001416750 | Chemo Mouthpiece | CHEMOMOUTHPIECE, LLC | 2024-05-23 |