FDA product code PKJ: Crown And Bridge Material, Resin Based
PKJ is the FDA product code for crown and bridge material, resin based. It is a Not classified device, reviewed by the Dental panel. Devices under PKJ reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
Used for dental crown restorations by single crown, bridge, etc, or for indirect repair of dental crown fabrications.
Classification
| Field | Value |
|---|---|
| Device name | Crown And Bridge Material, Resin Based |
| Device class | Not classified |
| Review panel | DE — Dental |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for PKJ devices
openFDA lists no recalls for product code PKJ.
Frequently asked questions
What is FDA product code PKJ?
PKJ is the FDA product code for crown and bridge material, resin based. It is a Not classified device, reviewed by the Dental panel.
What device class is PKJ?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code PKJ
- Run a recall and safety report across every PKJ manufacturer
- Watch product code PKJ 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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