Device recall
Z-0157-2012: 37% Etching Gel-5ml syringe, part #N01IB The intended use of these devices is to…
FDA device recall · Class III · Kerr/pentron Dba Kerr Corporation And Pentron Clinical
Key facts
| Recall number (Z-number) | Z-0157-2012 |
|---|---|
| Recall event | 60114 |
| Product | 37% Etching Gel-5ml syringe, part #N01IB The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. |
| Product code | EBF |
| Recalling firm | Kerr/pentron Dba Kerr Corporation And Pentron Clinical |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 9, 2012 |
| 510(k) numbers | K874189 |
| 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