QUA — Intraoral Cooling Device Class II
FDA product code QUA covers "Intraoral Cooling Device", a Class II medical device regulated under 21 CFR 872.5590. Submissions are reviewed by the Dental panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QUA
- Device Class
- Class II
- Regulation Number
- 872.5590
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
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