Device recall
Z-1708-2024: IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the…
FDA device recall · Class II · IVOCLAR VIVADENT AG
Key facts
| Recall number (Z-number) | Z-1708-2024 |
|---|---|
| Recall event | 94401 |
| Product | IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758443 |
| Product code | EIH |
| Recalling firm | IVOCLAR VIVADENT AG |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K051705 |
| FEI number | 3012909848 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database