FDA product code EFK: Forceps, Articulation Paper
EFK is the FDA product code for forceps, articulation paper. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. Devices under EFK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Forceps, Articulation Paper |
| Device class | Class I |
| Regulation | 21 CFR 872.4565 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Recalls for EFK devices
openFDA lists no recalls for product code EFK.
Frequently asked questions
What is FDA product code EFK?
EFK is the FDA product code for forceps, articulation paper. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EFK?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code EFK
- Run a recall and safety report across every EFK manufacturer
- Watch product code EFK 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.