Device recall
Z-2094-2025: TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based…
FDA device recall · Class III · STRATASYS LTD
Key facts
| Recall number (Z-number) | Z-2094-2025 |
|---|---|
| Recall event | 97021 |
| Product | TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances |
| Product code | EBI |
| Recalling firm | STRATASYS LTD |
| Recall class | Class III |
| Status | Completed |
| 510(k) numbers | K220771 |
| FEI number | 3017374693 |
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