BEUDAMED
    FDA Enforcement Class II Ongoing

    Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product Usage: For dentinal hypersensitivity and for the reduction of post-operative sensitivity.

    Recall: Z-0661-2020 · Reported December 18, 2019

    Enforcement

    Recall Number
    Z-0661-2020
    Event ID
    84249
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Young Dental Manufacturing Co, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 18, 2019
    Initiation Date
    October 30, 2019
    Classification Date
    December 9, 2019
    Address
    13705 Shoreline Ct E, N/A, Earth City, MO, 63045-1202, United States

    Description

    Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product Usage: For dentinal hypersensitivity and for the reduction of post-operative sensitivity.

    Reason

    Product shelf life may be shorter than that indicated on the label.

    Code Info

    Batch 84702; Batch 72766

    Distribution

    US Nationwide distribution in the states of MS, IN, MD, IL, TN, NJ, an ME.

    Quantity

    Batch 84702 - 6500 units; Batch 72766 - 6500 units