Device recall
Z-2129-2014: Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is…
FDA device recall · Class II · Novocol, Inc.
Key facts
| Recall number (Z-number) | Z-2129-2014 |
|---|---|
| Recall event | 68794 |
| Product | Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to adhere restorative material to the tooth during restorations. Package contains 100 0.125 mL unit dose tips, 100 applicator brushes, and a product insert. |
| Product code | KLE |
| Recalling firm | Novocol, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 31, 2014 |
| 510(k) numbers | K042614 |
| FEI number | 1721729 |
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