FDA product code EEA: Plate, Base, Shellac
EEA is the FDA product code for plate, base, shellac. It is a Class I device, regulated under 21 CFR 872.6200 and reviewed by the Dental panel. Devices under EEA reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Plate, Base, Shellac |
| Device class | Class I |
| Regulation | 21 CFR 872.6200 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for EEA devices
openFDA lists no recalls for product code EEA.
Frequently asked questions
What is FDA product code EEA?
EEA is the FDA product code for plate, base, shellac. It is a Class I device, regulated under 21 CFR 872.6200 and reviewed by the Dental panel.
What device class is EEA?
Class I, regulation 21 CFR 872.6200. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code EEA
- Run a recall and safety report across every EEA manufacturer
- Watch product code EEA 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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