FDA-Device2020-12-09Class III
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.
Talladium Inc
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.
Sold states
U.S. Nationwide distribution including in the states of PA, KS, OR, FL, CA.
Affected count
10
Manufactured in
27360 Muirfield Ln, N/A, Valencia, CA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0512-2021Don't want to check this manually?
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