FDA product code EMP: Marker, Periodontic
EMP is the FDA product code for marker, periodontic. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. Devices under EMP reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Marker, Periodontic |
| Device class | Class I |
| Regulation | 21 CFR 872.4565 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Recalls for EMP devices
openFDA lists no recalls for product code EMP.
Frequently asked questions
What is FDA product code EMP?
EMP is the FDA product code for marker, periodontic. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EMP?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code EMP
- Run a recall and safety report across every EMP manufacturer
- Watch product code EMP 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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