BEUDAMED
    FDA Enforcement Class II Terminated

    IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder + 325ml Liquid, REF 3746, Rx ONLY; Indicated for relining a denture surface

    Recall: Z-2098-2016 · Reported July 6, 2016

    Enforcement

    Recall Number
    Z-2098-2016
    Event ID
    74061
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CMP Industries, Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 6, 2016
    Initiation Date
    April 28, 2016
    Classification Date
    June 29, 2016
    Termination Date
    May 25, 2018
    Address
    413 N Pearl St, Albany, NY, 12207-1311, United States

    Description

    IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder + 325ml Liquid, REF 3746, Rx ONLY; Indicated for relining a denture surface

    Reason

    Possible presence of foreign material (rust).

    Code Info

    Lot Number: 79943 Expiration Date: March 2021

    Distribution

    Domestic - MI, MN, NJ, NM, NY & PA; International - Canada

    Quantity

    77 units Total