FDA product code ECC: Sterilizer, Glass Bead
ECC is the FDA product code for sterilizer, glass bead. It is a Class III device, regulated under 21 CFR 872.6730 and reviewed by the Dental panel. Devices under ECC reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Call for PMAs on 4/21/97 per 62 FR 2902 on 1/27/97
Classification
| Field | Value |
|---|---|
| Device name | Sterilizer, Glass Bead |
| Device class | Class III |
| Regulation | 21 CFR 872.6730 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | PMA |
Recalls for ECC devices
openFDA lists no recalls for product code ECC.
Frequently asked questions
What is FDA product code ECC?
ECC is the FDA product code for sterilizer, glass bead. It is a Class III device, regulated under 21 CFR 872.6730 and reviewed by the Dental panel.
What device class is ECC?
Class III, regulation 21 CFR 872.6730. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code ECC
- Run a recall and safety report across every ECC manufacturer
- Watch product code ECC 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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