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