Device recall
Z-1026-2016: Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and…
FDA device recall · Class II · Ivoclar Vivadent, Inc.
Key facts
| Recall number (Z-number) | Z-1026-2016 |
|---|---|
| Recall event | 73308 |
| Product | Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ---- COMMON/USUAL NAME: Pit & Fissure Sealant |
| Product code | EBC |
| Recalling firm | Ivoclar Vivadent, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 8, 2017 |
| 510(k) numbers | K813015 |
| FEI number | 1316092 |
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