Device recall
Z-3067-2024: Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles…
FDA device recall · Class II · Ultradent Products, Inc.
Key facts
| Recall number (Z-number) | Z-3067-2024 |
|---|---|
| Recall event | 95175 |
| Product | Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for direct and indirect posterior and anterior… |
| Product code | EBF |
| Recalling firm | Ultradent Products, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K201795 |
| 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