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