BEUDAMED
    FDA Enforcement Class II Terminated

    IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306. Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards

    Recall: Z-0292-2019 · Reported November 7, 2018

    Enforcement

    Recall Number
    Z-0292-2019
    Event ID
    81206
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CMP Industries, Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 7, 2018
    Initiation Date
    September 12, 2018
    Classification Date
    October 30, 2018
    Termination Date
    May 19, 2020
    Address
    413 N Pearl St, N/A, Albany, NY, 12207-1311, United States

    Description

    IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306. Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards

    Reason

    Foreign material in product

    Code Info

    Lot Number: 85623 , 85827

    Distribution

    Worldwide distribution, US Nationwide in the states of CA, FL, IL, MI, NY, OK, OR, PA, TX, WA and countries of Canada and Spain.

    Quantity

    400 units