FDA product code EHR: Pad, Denture, Over The Counter
EHR is the FDA product code for pad, denture, over the counter. It is a Class II device, regulated under 21 CFR 872.3540 and reviewed by the Dental panel. Devices under EHR reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Pad, Denture, Over The Counter |
| Device class | Class II |
| Regulation | 21 CFR 872.3540 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Recalls for EHR devices
openFDA lists no recalls for product code EHR.
Frequently asked questions
What is FDA product code EHR?
EHR is the FDA product code for pad, denture, over the counter. It is a Class II device, regulated under 21 CFR 872.3540 and reviewed by the Dental panel.
What device class is EHR?
Class II, regulation 21 CFR 872.3540. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code EHR
- Run a recall and safety report across every EHR manufacturer
- Watch product code EHR 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.