FDA product code KXW: Adhesive, Denture, Carboxymethylcellulose Sodium (49%) And Ethylene-Oxide Homopolymer
KXW is the FDA product code for adhesive, denture, carboxymethylcellulose sodium (49%) and ethylene-oxide homopolymer. It is a Class I device, regulated under 21 CFR 872.3410 and reviewed by the Dental panel. Devices under KXW reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Adhesive, Denture, Carboxymethylcellulose Sodium (49%) And Ethylene-Oxide Homopolymer |
| Device class | Class I |
| Regulation | 21 CFR 872.3410 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Recalls for KXW devices
openFDA lists no recalls for product code KXW.
Frequently asked questions
What is FDA product code KXW?
KXW is the FDA product code for adhesive, denture, carboxymethylcellulose sodium (49%) and ethylene-oxide homopolymer. It is a Class I device, regulated under 21 CFR 872.3410 and reviewed by the Dental panel.
What device class is KXW?
Class I, regulation 21 CFR 872.3410. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code KXW
- Run a recall and safety report across every KXW manufacturer
- Watch product code KXW 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.
All Dental product codes · FDA product code lookup · 510(k) database search · 510(k) review times