FDA product code NKJ: Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter
NKJ is the FDA product code for cushion, pad, denture, wax impregnated cotton, over the counter. It is a Class I device, regulated under 21 CFR 872.3540 and reviewed by the Dental panel. Devices under NKJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
OTC denture cushion or pad made of wax impregnated cotton cloth that the patient applies to the base or inner surface of a denture before inserting the denture into the mouth. The Device is intended to be discarded following 1 day's use.
Classification
| Field | Value |
|---|---|
| Device name | Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter |
| Device class | Class I |
| Regulation | 21 CFR 872.3540 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Recalls for NKJ devices
openFDA lists no recalls for product code NKJ.
Frequently asked questions
What is FDA product code NKJ?
NKJ is the FDA product code for cushion, pad, denture, wax impregnated cotton, over the counter. It is a Class I device, regulated under 21 CFR 872.3540 and reviewed by the Dental panel.
What device class is NKJ?
Class I, regulation 21 CFR 872.3540. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code NKJ
- Run a recall and safety report across every NKJ manufacturer
- Watch product code NKJ 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.