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Intraoral Cooling Device

FDA product code QUA · 1 cleared devices

Class 2 Dental
Regulation
21 CFR 872.5590
Review panel
DE
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2024-01-23 – 2024-01-23

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

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