Device recall
Z-0035-2017: Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental…
FDA device recall · Class II · Ivoclar Vivadent, Inc.
Key facts
| Recall number (Z-number) | Z-0035-2017 |
|---|---|
| Recall event | 74320 |
| Product | Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain |
| Product code | EIH |
| Recalling firm | Ivoclar Vivadent, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 14, 2018 |
| 510(k) numbers | K152118 |
| FEI number | 1316092 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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