QUA · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.5590
Classification
FDA Product Code
QUA
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 872.5590
Review panel
DE
Medical specialty
Dental
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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