FDA product code HBD: Handpiece (Brace), Drill
HBD is the FDA product code for handpiece (brace), drill. It is a Class I device, regulated under 21 CFR 882.4325 and reviewed by the Neurology panel. Devices under HBD reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Handpiece (Brace), Drill |
| Device class | Class I |
| Regulation | 21 CFR 882.4325 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
Recalls for HBD devices
openFDA lists no recalls for product code HBD.
Frequently asked questions
What is FDA product code HBD?
HBD is the FDA product code for handpiece (brace), drill. It is a Class I device, regulated under 21 CFR 882.4325 and reviewed by the Neurology panel.
What device class is HBD?
Class I, regulation 21 CFR 882.4325. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HBD
- Run a recall and safety report across every HBD manufacturer
- Watch product code HBD 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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