Device recall
Z-0213-2016: Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment…
FDA device recall · Class II · Ivoclar A. G.
Key facts
| Recall number (Z-number) | Z-0213-2016 |
|---|---|
| Recall event | 72290 |
| Product | Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed foil bag. Helioseal F is a light-curing, white-shaded fissure sealant featuring… |
| Product code | EBC |
| Recalling firm | Ivoclar A. G. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 14, 2016 |
| 510(k) numbers | K932078 |
| FEI number | 3002808636 |
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