FDA product code SBC: Dental Image Analyzer
SBC is the FDA product code for dental image analyzer. It is a Class II device, regulated under 21 CFR 872.1770 and reviewed by the Dental panel. Devices under SBC reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A dental image analyzer is a prescription home use device that uses software intended to collect and analyze patient-specific, optical camera-based, intraoral images. The analyses are provided to dental health care professionals as an aid to diagnosis of oral health conditions and/or to monitor treatment progress.
Classification
| Field | Value |
|---|---|
| Device name | Dental Image Analyzer |
| Device class | Class II |
| Regulation | 21 CFR 872.1770 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
Recalls for SBC devices
openFDA lists no recalls for product code SBC.
Frequently asked questions
What is FDA product code SBC?
SBC is the FDA product code for dental image analyzer. It is a Class II device, regulated under 21 CFR 872.1770 and reviewed by the Dental panel.
What device class is SBC?
Class II, regulation 21 CFR 872.1770. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SBC
- Run a recall and safety report across every SBC manufacturer
- Watch product code SBC 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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