Device 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.
Z-0512-2021
Product summary
- Firm
- Talladium Inc
- Event
- Event 86614
- Status
- Terminated
- Classification
- Class III
- Quantity
- 10
- Official record key
device-enforcement:Z-0512-2021
Official wording
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.
Code information: Lot No. 1BKI
Distribution pattern: U.S. Nationwide distribution including in the states of PA, KS, OR, FL, CA.
Derived failure modes
-
Labeling or packaging
incorrect label