Product code
PKJ: Crown and bridge material, resin based
FDA product code · Not Classified · Dental
Key facts
| Product code | PKJ |
|---|---|
| Device | Crown and bridge material, resin based |
| Device class | Not Classified |
| Review panel | Dental |
| Submission type | Contact ODE |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Used for dental crown restorations by single crown, bridge, etc, or for indirect repair of dental crown fabrications. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1,000+ UDI devices (GUDID)
- 1–9 MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database