BEUDAMED
    FDA Enforcement Class II Terminated

    DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F

    Recall: Z-2436-2019 · Reported September 11, 2019

    Enforcement

    Recall Number
    Z-2436-2019
    Event ID
    83396
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Coltene /Whaledent AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 11, 2019
    Initiation Date
    July 19, 2019
    Classification Date
    August 30, 2019
    Termination Date
    April 30, 2021
    Address
    Feldwiesenstrasse 20, N/A, Altstatten Sg, N/A, N/A, Switzerland

    Description

    DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F

    Reason

    A single batch of Diatech Diamond dental burs, 856-016-7-F, Round end taper, contain diamond burs with the same grit size (fine) and shape (round end taper) but different length.

    Code Info

    Lot/Batch Number J22952

    Distribution

    GA

    Quantity

    20 units of 5 burs/unit