510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
QUAClass II

Intraoral Cooling Device

21 CFR 872.5590 / Dental
FDA source (opens on fda.gov)

QUA is the FDA product code for Intraoral Cooling Device, a class II device type, regulated under 21 CFR 872.5590. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QUA
Device name
Intraoral Cooling Device
FDA 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
Regulation
21 CFR 872.5590
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QUA

By decision year
2 clearances under product code QUA with a decision year between 2022 and 2024, 2022 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QUA by decision year
YearClearances
20221
20241

Applicants with the most clearances

Product code QUA
Applicants holding the most 510(k) clearances under product code QUA
ApplicantClearances
Braincool AB1
Chemo Mouthpiece, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code