BEUDAMED
    FDA Enforcement Class II Terminated

    UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. Product Usage: The UltraSeal XT Plus is used for prophylactic sealing of pits and fissures. It may also be used for micro restorative or initial layer of composite restorations.

    Recall: Z-0704-2017 · Reported December 14, 2016

    Enforcement

    Recall Number
    Z-0704-2017
    Event ID
    75796
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ultradent Products, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 14, 2016
    Initiation Date
    November 17, 2016
    Classification Date
    December 3, 2016
    Termination Date
    June 5, 2017
    Address
    505 W 10200 S, N/A, South Jordan, UT, 84095-3800, United States

    Description

    UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. Product Usage: The UltraSeal XT Plus is used for prophylactic sealing of pits and fissures. It may also be used for micro restorative or initial layer of composite restorations.

    Reason

    There was a labeling error with product, UltraSeal XT Plus Clear Refill, Part Number (PN) 565, Lot Number (Lot) BD79T. The package was mislabeled as PQ1, PN 641; while the barcode, IFU and products were labeled for UltraSeal XT Plus Clear Refill, PN 565, Lot BD79T.

    Code Info

    Lot BD79T

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

    31