Device recall
Z-1697-2008: Dental Cement-Bisco BISCEM Dual-Cured Self-Adhesive Resin Cement, Opaque; The…
FDA device recall · Class II · Bisco Inc
Key facts
| Recall number (Z-number) | Z-1697-2008 |
|---|---|
| Recall event | 47871 |
| Product | Dental Cement-Bisco BISCEM Dual-Cured Self-Adhesive Resin Cement, Opaque; The product is intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the pulp. |
| Product code | EMA |
| Recalling firm | Bisco Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 14, 2010 |
| 510(k) numbers | K060701 |
| FEI number | 1420052 |
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