FDA product code EKF: Instrument, Contouring, Matrix, Operative
EKF is the FDA product code for instrument, contouring, matrix, operative. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. Devices under EKF reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Contouring, Matrix, Operative |
| Device class | Class I |
| Regulation | 21 CFR 872.4565 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Recalls for EKF devices
openFDA lists no recalls for product code EKF.
Frequently asked questions
What is FDA product code EKF?
EKF is the FDA product code for instrument, contouring, matrix, operative. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EKF?
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 EKF
- Run a recall and safety report across every EKF manufacturer
- Watch product code EKF 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.