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