BEUDAMED
    FDA Enforcement Class II Terminated

    IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray used in the fabrication of dental restorations

    Recall: Z-2265-2015 · Reported August 5, 2015

    Enforcement

    Recall Number
    Z-2265-2015
    Event ID
    71636
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ivoclar Vivadent, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 5, 2015
    Initiation Date
    July 9, 2015
    Classification Date
    July 27, 2015
    Termination Date
    May 27, 2016
    Address
    175 Pineview Dr, N/A, Buffalo, NY, 14228-2231, United States

    Description

    IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray used in the fabrication of dental restorations

    Reason

    Complaints were received of coarse particles in the glazed surface of IPS e.max Ceram restorations. A basic component of the glass contains a higher number of large grain sizes than usual.

    Code Info

    Batch U15124

    Distribution

    US Distribution in the states of: PA, IN, IA and SC.

    Quantity

    Domestic: 27 units