Device recall
Z-1150-2010: Bond-1 Primer/Adhesive. The intended use of this device is adhesion to dentin of…
FDA device recall · Class II · Sybron Dental Specialties
Key facts
| Recall number (Z-number) | Z-1150-2010 |
|---|---|
| Recall event | 54490 |
| Product | Bond-1 Primer/Adhesive. The intended use of this device is adhesion to dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi-precious and non-precious alloys, porcelain… |
| Product code | KLE |
| Recalling firm | Sybron Dental Specialties |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 24, 2012 |
| 510(k) numbers | K973388 |
| 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