FDA product code ELJ: Teeth, Artificial, Posterior With Metal Insert
ELJ is the FDA product code for teeth, artificial, posterior with metal insert. It is a Class I device, regulated under 21 CFR 872.3900 and reviewed by the Dental panel. Devices under ELJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Teeth, Artificial, Posterior With Metal Insert |
| Device class | Class I |
| Regulation | 21 CFR 872.3900 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Recalls for ELJ devices
openFDA lists no recalls for product code ELJ.
Frequently asked questions
What is FDA product code ELJ?
ELJ is the FDA product code for teeth, artificial, posterior with metal insert. It is a Class I device, regulated under 21 CFR 872.3900 and reviewed by the Dental panel.
What device class is ELJ?
Class I, regulation 21 CFR 872.3900. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code ELJ
- Run a recall and safety report across every ELJ manufacturer
- Watch product code ELJ 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.