QUA — Intraoral Cooling Device Class II

FDA Device Classification

Classification Details

Product Code: QUA
Device Class: Class II
Regulation Number: 872.5590
Submission Type
Review Panel: DE
Medical Specialty: Dental
Implant: No

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

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K232917	chemo mouthpiece	Chemo Mouthpiece	January 23, 2024
DEN210027	braincool	The Cooral System	October 14, 2022