BEUDAMED
    FDA Enforcement Class II Ongoing

    CustMbite, Model Number CBT-SRS-UL

    Recall: Z-1494-2022 · Reported August 10, 2022

    Enforcement

    Recall Number
    Z-1494-2022
    Event ID
    90639
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Dental Choice Holding Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 10, 2022
    Initiation Date
    May 23, 2022
    Classification Date
    August 2, 2022
    Address
    10100 Linn Station Rd, N/A, Louisville, KY, 40223-3861, United States

    Description

    CustMbite, Model Number CBT-SRS-UL

    Reason

    The device was marketed and sold in the US without FDA clearance.

    Code Info

    UDI-DI: N/a Lot codes: SS-J21287-200-1021, SS-K21333-510-1121, SS-B22040-305-0222

    Distribution

    US Nationwide distribution.

    Quantity

    708