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