FDA product code ECN: Clamp, Wire, Orthodontic
ECN is the FDA product code for clamp, wire, orthodontic. It is a Class I device, regulated under 21 CFR 872.5410 and reviewed by the Dental panel. Devices under ECN reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 10 recalls for ECN devices.
Classification
| Field | Value |
|---|---|
| Device name | Clamp, Wire, Orthodontic |
| Device class | Class I |
| Regulation | 21 CFR 872.5410 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Recalls for ECN devices
10 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-03-09.
Frequently asked questions
What is FDA product code ECN?
ECN is the FDA product code for clamp, wire, orthodontic. It is a Class I device, regulated under 21 CFR 872.5410 and reviewed by the Dental panel.
What device class is ECN?
Class I, regulation 21 CFR 872.5410. Typical premarket route: 510(k) exempt.
Have ECN devices been recalled?
Yes: 10 product recalls across 1 recall events; the most recent began 2015-03-09.
Next steps
- Run an FDA pathway report with predicate devices for product code ECN
- Run a recall and safety report across every ECN manufacturer
- Watch product code ECN 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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