FDA product code KOR: Adhesive, Denture, Karaya With Sodium Borate
KOR is the FDA product code for adhesive, denture, karaya with sodium borate. It is a Class III device, regulated under 21 CFR 872.3400 and reviewed by the Dental panel. Devices under KOR reach the market by PMA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Adhesive, Denture, Karaya With Sodium Borate |
| Device class | Class III |
| Regulation | 21 CFR 872.3400 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | PMA |
Recalls for KOR devices
openFDA lists no recalls for product code KOR.
Frequently asked questions
What is FDA product code KOR?
KOR is the FDA product code for adhesive, denture, karaya with sodium borate. It is a Class III device, regulated under 21 CFR 872.3400 and reviewed by the Dental panel.
What device class is KOR?
Class III, regulation 21 CFR 872.3400. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code KOR
- Run a recall and safety report across every KOR manufacturer
- Watch product code KOR 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