Device recall
Z-0035-2008: Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component…
FDA device recall · Class III · Heraeus Kulzer Inc., Dental Products Division
Key facts
| Recall number (Z-number) | Z-0035-2008 |
|---|---|
| Recall event | 44827 |
| Product | Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710. |
| Product code | KLE |
| Recalling firm | Heraeus Kulzer Inc., Dental Products Division |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 12, 2008 |
| 510(k) numbers | K992292 |
| FEI number | 1821514 |
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