Device recall
Z-1839-2020: Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental…
FDA device recall · Class II · Ivoclar Vivadent AG
Key facts
| Recall number (Z-number) | Z-1839-2020 |
|---|---|
| Recall event | 85450 |
| Product | Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686195 |
| Product code | EIH |
| Recalling firm | Ivoclar Vivadent AG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 22, 2021 |
| 510(k) numbers | K051705 |
| FEI number | 3002808636 |
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