BEUDAMED
    FDA Enforcement Class III Terminated

    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.

    Recall: Z-0512-2021 · Reported December 9, 2020

    Enforcement

    Recall Number
    Z-0512-2021
    Event ID
    86614
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Talladium Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 9, 2020
    Initiation Date
    October 9, 2020
    Classification Date
    December 1, 2020
    Termination Date
    August 17, 2022
    Address
    27360 Muirfield Ln, N/A, Valencia, CA, 91355-1010, United States

    Description

    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

    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 Info

    Lot No. 1BKI

    Distribution

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

    Quantity

    10