BEUDAMED
    FDA Enforcement Class II Terminated

    OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol Assortment: REF/Product ID 634464 --Device Listing # B106952. One step polishing system for all common dental composites and amalgam.

    Recall: Z-2373-2016 · Reported August 17, 2016

    Enforcement

    Recall Number
    Z-2373-2016
    Event ID
    74622
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ivoclar Vivadent, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 17, 2016
    Initiation Date
    July 11, 2016
    Classification Date
    August 9, 2016
    Termination Date
    September 22, 2017
    Address
    175 Pineview Dr, Amherst, NY, 14228-2231, United States

    Description

    OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol Assortment: REF/Product ID 634464 --Device Listing # B106952. One step polishing system for all common dental composites and amalgam.

    Reason

    After a few seconds of polishing with moderate force, parts of the OptraPol cup are breaking away. OptraPol Small Flame is also affected. Two complaints were filed referring to OptraPol, claiming that the abrasive polishers wear faster than expected.

    Code Info

    REF/Product ID 634459: Lot UL0843; REF/Product ID 634458: Lot VL0704; REF/Product ID 634464: Lot VL0705.

    Distribution

    Distributed in the states of CA, FL, GA, IA, IL, IN, KS, KY, MA, MI, NV, NY, OH, PA, TX, and WA.

    Quantity

    US: 86 units total