FDA Product Code QUA: Intraoral Cooling Device
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
Leading manufacturers include Braincool AB and Chemo Mouthpiece, LLC.
FDA 510(k) Cleared Intraoral Cooling Device Devices (Product Code QUA)
About Product Code QUA - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QUA since 2022, with 1 receiving FDA clearance (average review time: 298 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
QUA devices are reviewed by the Dental panel. Browse all Dental devices →