FDA product code KOS: Adhesive, Denture, Carboxymethylcellulose Sodium And Cationic Polyacrylamide Polymer
KOS is the FDA product code for adhesive, denture, carboxymethylcellulose sodium and cationic polyacrylamide polymer. It is a Class III device, regulated under 21 CFR 872.3420 and reviewed by the Dental panel. Devices under KOS reach the market by PMA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Adhesive, Denture, Carboxymethylcellulose Sodium And Cationic Polyacrylamide Polymer |
| Device class | Class III |
| Regulation | 21 CFR 872.3420 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | PMA |
Recalls for KOS devices
openFDA lists no recalls for product code KOS.
Frequently asked questions
What is FDA product code KOS?
KOS is the FDA product code for adhesive, denture, carboxymethylcellulose sodium and cationic polyacrylamide polymer. It is a Class III device, regulated under 21 CFR 872.3420 and reviewed by the Dental panel.
What device class is KOS?
Class III, regulation 21 CFR 872.3420. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code KOS
- Run a recall and safety report across every KOS manufacturer
- Watch product code KOS 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.