FDA product code QJX: Caries Detection Product With Drug Or Biologic
QJX is the FDA product code for caries detection product with drug or biologic. It is a Class III device, reviewed by the Dental panel. Devices under QJX reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
Intended to aid in the detection of tooth decay by measuring increased visible light, fluorescence, or luminescence induced by caries-activated drug or biologic.
Classification
| Field | Value |
|---|---|
| Device name | Caries Detection Product With Drug Or Biologic |
| Device class | Class III |
| Review panel | DE — Dental |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QJX devices
openFDA lists no recalls for product code QJX.
Frequently asked questions
What is FDA product code QJX?
QJX is the FDA product code for caries detection product with drug or biologic. It is a Class III device, reviewed by the Dental panel.
What device class is QJX?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QJX
- Run a recall and safety report across every QJX manufacturer
- Watch product code QJX 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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