Device recall
Z-3066-2024: Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog…
FDA device recall · Class II · Ultradent Products, Inc.
Key facts
| Recall number (Z-number) | Z-3066-2024 |
|---|---|
| Recall event | 95175 |
| Product | Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A Product Description: Vit-l-escence composite is a light-cured, microhybrid, Bis-GMA esthetic composite restorative material. It is 75% filled by weight, 52% filled by volume with 0.7 m… |
| Product code | EBF |
| Recalling firm | Ultradent Products, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K974282 |
| 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