Device recall
Z-0916-2010: Herculite Ultra (Part Number 34333), dental composite resorative material…
FDA device recall · Class III · Sybron Dental Specialties
Key facts
| Recall number (Z-number) | Z-0916-2010 |
|---|---|
| Recall event | 53431 |
| Product | Herculite Ultra (Part Number 34333), dental composite resorative material. Manufactured by Kerr Corporation, Orange, CA. |
| Product code | EBF |
| Recalling firm | Sybron Dental Specialties |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 19, 2012 |
| 510(k) numbers | K082671 |
| FEI number | 2024312 |
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