FDA product code NFE: Materials, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Alveolar Ridge Augmentation
NFE is the FDA product code for materials, polytetrafluoroethylene vitreous carbon, for maxillofacial alveolar ridge augmentation. It is a Class II device, regulated under 21 CFR 872.3680 and reviewed by the Dental panel. Devices under NFE reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Materials, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Alveolar Ridge Augmentation |
| Device class | Class II |
| Regulation | 21 CFR 872.3680 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
Recalls for NFE devices
openFDA lists no recalls for product code NFE.
Frequently asked questions
What is FDA product code NFE?
NFE is the FDA product code for materials, polytetrafluoroethylene vitreous carbon, for maxillofacial alveolar ridge augmentation. It is a Class II device, regulated under 21 CFR 872.3680 and reviewed by the Dental panel.
What device class is NFE?
Class II, regulation 21 CFR 872.3680. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NFE
- Run a recall and safety report across every NFE manufacturer
- Watch product code NFE 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.