BEUDAMED
    FDA Enforcement Class II Ongoing

    BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish

    Recall: Z-1697-2023 · Reported June 14, 2023

    Enforcement

    Recall Number
    Z-1697-2023
    Event ID
    92401
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Young Dental Manufacturing I, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 14, 2023
    Initiation Date
    May 23, 2023
    Classification Date
    June 8, 2023
    Address
    13705 Shoreline Ct E, Earth City, MO, 63045-1202, United States

    Description

    BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish

    Reason

    The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum.

    Code Info

    UDI/DI 00366975000590, Lot number 207540, Exp. 20240930

    Distribution

    US distribution to Florida, Nevada, and Pennsylvania.

    Quantity

    344 boxes