FDA product code QJK: Intraoral Camera
QJK is the FDA product code for intraoral camera. It is a Class II device, regulated under 21 CFR 872.3661 and reviewed by the Dental panel. Devices under QJK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
To capture the topographical characteristics of teeth or a stone model
Classification
| Field | Value |
|---|---|
| Device name | Intraoral Camera |
| Device class | Class II |
| Regulation | 21 CFR 872.3661 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Recalls for QJK devices
openFDA lists no recalls for product code QJK.
Frequently asked questions
What is FDA product code QJK?
QJK is the FDA product code for intraoral camera. It is a Class II device, regulated under 21 CFR 872.3661 and reviewed by the Dental panel.
What device class is QJK?
Class II, regulation 21 CFR 872.3661. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QJK
- Run a recall and safety report across every QJK manufacturer
- Watch product code QJK 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.