FDAOctober 9, 2020device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
talladium
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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