Device recall
Z-0053-2021: PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light…
FDA device recall · Class II · Ultradent Products, Inc.
Key facts
| Recall number (Z-number) | Z-0053-2021 |
|---|---|
| Recall event | 86432 |
| Product | PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1m average particle size with narrow upper limit particle distribution. |
| Product code | EBF |
| Recalling firm | Ultradent Products, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 18, 2021 |
| 510(k) numbers | K974413 |
| 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