Device recall
Z-0454-2012: Dental cement under the brand name Cement-It and Natural Elegance (private label…
FDA device recall · Class II · Kerr/pentron Dba Kerr Corporation And Pentron Clinical
Key facts
| Recall number (Z-number) | Z-0454-2012 |
|---|---|
| Recall event | 60359 |
| Product | Dental cement under the brand name Cement-It and Natural Elegance (private label of Cement-It). The intended use of this device is to affix dental devices such as crowns or bridges onto the tooth. Cement-It and Natural Elegance (private label of Cement-It) are indicated as a luting cement bonding… |
| Product code | EMA |
| Recalling firm | Kerr/pentron Dba Kerr Corporation And Pentron Clinical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 22, 2014 |
| 510(k) numbers | K000173 |
| 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