BEUDAMED
    FDA Enforcement Class II Terminated

    Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.

    Recall: Z-0741-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0741-2018
    Event ID
    78479
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cosmedent, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 7, 2018
    Initiation Date
    September 28, 2017
    Classification Date
    February 27, 2018
    Termination Date
    October 5, 2020
    Address
    4646 N Ravenswood Ave, N/A, Chicago, IL, 60640-4510, United States

    Description

    Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.

    Reason

    Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.

    Code Info

    SKU #663-103, Lot No. 164222A, Exp. Date 10/31/2019

    Distribution

    Worldwide Distribution -- USA, to the states of IL, LA, MI, PA, and WI; and, to the countries of Australia, Hungary, and Spain.

    Quantity

    84 units