FDA product code QJJ: Indirect Bonding Tray
QJJ is the FDA product code for indirect bonding tray. It is a Class I device, regulated under 21 CFR 872.5410 and reviewed by the Dental panel. Devices under QJJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
A tray or splint to enable bonding of multiple orthodontic brackets to tooth surfaces.
Classification
| Field | Value |
|---|---|
| Device name | Indirect Bonding Tray |
| Device class | Class I |
| Regulation | 21 CFR 872.5410 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Recalls for QJJ devices
openFDA lists no recalls for product code QJJ.
Frequently asked questions
What is FDA product code QJJ?
QJJ is the FDA product code for indirect bonding tray. It is a Class I device, regulated under 21 CFR 872.5410 and reviewed by the Dental panel.
What device class is QJJ?
Class I, regulation 21 CFR 872.5410. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QJJ
- Run a recall and safety report across every QJJ manufacturer
- Watch product code QJJ 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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