# FDA recall Z-0512-2021

> **Talladium Inc** · Class III · device recall initiated 2020-10-09.

## 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.

## Reason for recall

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.

## Distribution

U.S. Nationwide distribution including in the states of PA, KS, OR, FL, CA.

## Key facts

- **Recall number:** Z-0512-2021
- **Recalling firm:** Talladium Inc
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-09
- **Report date:** 2020-12-09
- **Termination date:** 2022-08-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Valencia, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0512-2021

## Citation

> AI Analytics. FDA recall Z-0512-2021. Retrieved 2026-08-19 from https://api.ai-analytics.org/recall/Z-0512-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*