Device recall
Z-0512-2021: Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling…
FDA device recall · Class III · Talladium Inc
Key facts
| Recall number (Z-number) | Z-0512-2021 |
|---|---|
| Recall event | 86614 |
| Product | Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling blank in the fabrication of provisional crowns and bridges. All blanks are solely used by a Trained Dental Technician or on the order of a dental professional. |
| Product code | EBG |
| Recalling firm | Talladium Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 17, 2022 |
| 510(k) numbers | K142371 |
| FEI number | 2023129 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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