FDA product code EFX: Protector, Silicate
EFX is the FDA product code for protector, silicate. It is a Class I device, regulated under 21 CFR 872.6670 and reviewed by the Dental panel. Devices under EFX reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Protector, Silicate |
| Device class | Class I |
| Regulation | 21 CFR 872.6670 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for EFX devices
openFDA lists no recalls for product code EFX.
Frequently asked questions
What is FDA product code EFX?
EFX is the FDA product code for protector, silicate. It is a Class I device, regulated under 21 CFR 872.6670 and reviewed by the Dental panel.
What device class is EFX?
Class I, regulation 21 CFR 872.6670. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code EFX
- Run a recall and safety report across every EFX manufacturer
- Watch product code EFX 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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