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