Device recall
Z-1368-2022: Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond…
FDA device recall · Class II · Ultradent Products, Inc.
Key facts
| Recall number (Z-number) | Z-1368-2022 |
|---|---|
| Recall event | 90434 |
| Product | Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Primer 4pk Refill, Part: 5135; Peak Universal Bond Sample SE, Part: S4554. For use in light-curing dental bonding procedures. |
| Product code | KLE |
| Recalling firm | Ultradent Products, Inc. |
| Recall class | Class II |
| Status | Completed |
| 510(k) numbers | K063558 |
| FEI number | 1718912 |
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