FDA product code NUX: Cleanser, Denture, Prescription
NUX is the FDA product code for cleanser, denture, prescription. It is a Class I device, regulated under 21 CFR 872.3520 and reviewed by the Dental panel. Devices under NUX reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Effervescent tablet for the removal of micro-organisms from removable dentures and retainers.
Classification
| Field | Value |
|---|---|
| Device name | Cleanser, Denture, Prescription |
| Device class | Class I |
| Regulation | 21 CFR 872.3520 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Recalls for NUX devices
openFDA lists no recalls for product code NUX.
Frequently asked questions
What is FDA product code NUX?
NUX is the FDA product code for cleanser, denture, prescription. It is a Class I device, regulated under 21 CFR 872.3520 and reviewed by the Dental panel.
What device class is NUX?
Class I, regulation 21 CFR 872.3520. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code NUX
- Run a recall and safety report across every NUX manufacturer
- Watch product code NUX 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.