FDA product code ELO: Cusp, Gold And Stainless Steel
ELO is the FDA product code for cusp, gold and stainless steel. It is a Class I device, regulated under 21 CFR 872.3350 and reviewed by the Dental panel. Devices under ELO reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Cusp, Gold And Stainless Steel |
| Device class | Class I |
| Regulation | 21 CFR 872.3350 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Recalls for ELO devices
openFDA lists no recalls for product code ELO.
Frequently asked questions
What is FDA product code ELO?
ELO is the FDA product code for cusp, gold and stainless steel. It is a Class I device, regulated under 21 CFR 872.3350 and reviewed by the Dental panel.
What device class is ELO?
Class I, regulation 21 CFR 872.3350. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code ELO
- Run a recall and safety report across every ELO manufacturer
- Watch product code ELO 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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