Device recall
Z-0482-2010: TempSpan Dual-Cure Temporary Crown and Bridge Material, PART NUMBER N69AD, The…
FDA device recall · Class II · Jeneric/Pentron
Key facts
| Recall number (Z-number) | Z-0482-2010 |
|---|---|
| Recall event | 53673 |
| Product | TempSpan Dual-Cure Temporary Crown and Bridge Material, PART NUMBER N69AD, The intended use of this device is to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated. |
| Product code | EBG |
| Recalling firm | Jeneric/Pentron |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 19, 2012 |
| 510(k) numbers | K021457 |
| FEI number | 3002803083 |
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