DeviceClearance

Product code QUA— Dental

Chemo Mouthpiece

Classification name
Intraoral Cooling Device
Device class
Class 2
Regulation
21 CFR 872.5590
Advisory panel
Dental
Total cleared
2
First cleared
Most recent

FDA classification 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”

— U.S. Food and Drug Administration, device classification record for product code QUA under 21 CFR 872.5590, via openFDA

Market context for product code QUA

FDA has cleared 2 devices under product code QUA between 2022 and 2024, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QUA

Recent clearances under product code QUA

Data sourced from openFDA. This site is unofficial and independent of the FDA.