Device recall
Z-0704-2017: UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT…
FDA device recall · Class II · Ultradent Products, Inc.
Key facts
| Recall number (Z-number) | Z-0704-2017 |
|---|---|
| Recall event | 75796 |
| Product | UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. Product Usage: The UltraSeal XT Plus is used for prophylactic sealing of pits and fissures. It may also be used for micro restorative or initial layer of composite restorations. |
| Product code | EBC |
| Recalling firm | Ultradent Products, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 5, 2017 |
| 510(k) numbers | K993846 |
| FEI number | 1718912 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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