Class III — Talladium Inc
| Recalling firm | TALLADIUM, INC. |
|---|---|
| Registered facility | TALLADIUM, INC. (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | Heat-cured polymethylmethacrylate (PMMA) milling blank product used to make long-term temporary crowns and bridge restorations has incorrect label. label states Part no. 5336-B1 (98x20mm). However, the item inside the box was Part no. 4302-B1 (95x20mm). An incorrect label may result in compatibility issues when setting up the disc with milling machine fixtures due to size variation. |
| 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. |
| Quantity | 10 |
| Distribution | U.S. Nationwide distribution including in the states of PA, KS, OR, FL, CA. |
| Initiated | 2020-10-09 |
| Classified | 2020-12-01 |
| Terminated | 2022-08-17 |
| Recall number | Z-0512-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Talladium Inc (Z-0512-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86614/
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