FDA product code NXJ: Denture, Cosmetic Only
NXJ is the FDA product code for denture, cosmetic only. It is a Not classified device, reviewed by the Dental panel. Devices under NXJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Intended to improve an individual's appearance only. Not intended to assist in chewing food.
Classification
| Field | Value |
|---|---|
| Device name | Denture, Cosmetic Only |
| Device class | Not classified |
| Review panel | DE — Dental |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
Recalls for NXJ devices
openFDA lists no recalls for product code NXJ.
Frequently asked questions
What is FDA product code NXJ?
NXJ is the FDA product code for denture, cosmetic only. It is a Not classified device, reviewed by the Dental panel.
What device class is NXJ?
Not classified. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code NXJ
- Run a recall and safety report across every NXJ manufacturer
- Watch product code NXJ 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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