FDA product code QUA: Intraoral Cooling Device
QUA is the FDA product code for intraoral cooling device. It is a Class II device, regulated under 21 CFR 872.5590 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under QUA, 1 in the last five years. The average 510(k) review took 126 days (median 126); 126 days on average over the last three years. 1 De Novo request was granted under it.
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
Classification
| Field | Value |
|---|---|
| Device name | Intraoral Cooling Device |
| Device class | Class II |
| Regulation | 21 CFR 872.5590 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
510(k) clearances per year for QUA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 126 |
Compare with all 510(k) review times · Search every QUA clearance
Top QUA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Chemo Mouthpiece, LLC | 1 | 2024-01-23 |
Most recent QUA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232917 | Chemo Mouthpiece, LLC | Chemo Mouthpiece | 2024-01-23 | 126 |
Recalls for QUA devices
openFDA lists no recalls for product code QUA.
Frequently asked questions
What is FDA product code QUA?
QUA is the FDA product code for intraoral cooling device. It is a Class II device, regulated under 21 CFR 872.5590 and reviewed by the Dental panel.
What device class is QUA?
Class II, regulation 21 CFR 872.5590. Typical premarket route: 510(k).
How long does a 510(k) take for product code QUA?
Across 1 cleared submissions the average was 126 days from receipt to decision (median 126).
Which companies have the most QUA clearances?
Chemo Mouthpiece, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QUA
- Run a recall and safety report across every QUA manufacturer
- Watch product code QUA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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