BEUDAMED
    FDA Enforcement Class II Terminated

    ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations

    Recall: Z-0376-2014 · Reported November 27, 2013

    Enforcement

    Recall Number
    Z-0376-2014
    Event ID
    66359
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ivoclar Vivadent, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    November 27, 2013
    Initiation Date
    September 23, 2013
    Classification Date
    November 21, 2013
    Termination Date
    May 27, 2016
    Address
    175 Pineview Dr, Buffalo, NY, 14228-2231, United States

    Description

    ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations

    Reason

    Ivoclar Vivadent, Inc. is recalling a lot of ExciTE F DSC Dental Adhesive found to produce a blue green discoloration when used in combination with cements.

    Code Info

    Product Code 630378AN; Lot Number: R59595; Expiration date of 3 January 2015

    Distribution

    US Distribution: including states of PA, WA, WI, NY, LA, TX, NJ, CA, OR, IA, SC, IN, IL, and AZ.

    Quantity

    63 refill packs (50 single use applications per refill)