FDA product code EAS: Gel, Electrode, For Pulp Tester
EAS is the FDA product code for gel, electrode, for pulp tester. It is a Class I device, regulated under 21 CFR 872.1730 and reviewed by the Dental panel. Devices under EAS reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Gel, Electrode, For Pulp Tester |
| Device class | Class I |
| Regulation | 21 CFR 872.1730 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Recalls for EAS devices
openFDA lists no recalls for product code EAS.
Frequently asked questions
What is FDA product code EAS?
EAS is the FDA product code for gel, electrode, for pulp tester. It is a Class I device, regulated under 21 CFR 872.1730 and reviewed by the Dental panel.
What device class is EAS?
Class I, regulation 21 CFR 872.1730. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code EAS
- Run a recall and safety report across every EAS manufacturer
- Watch product code EAS 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.