BEUDAMED
    FDA Enforcement Class II Ongoing

    KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. Model (Ref) #: 4220005

    Recall: Z-2336-2021 · Reported September 1, 2021

    Enforcement

    Recall Number
    Z-2336-2021
    Event ID
    88427
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Straumann USA LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 1, 2021
    Initiation Date
    June 25, 2021
    Classification Date
    August 24, 2021
    Address
    60 Minuteman Rd, N/A, Andover, MA, 01810-1008, United States

    Description

    KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. Model (Ref) #: 4220005

    Reason

    Product label intended for the European community was distributed to the USA market via their US distribution organization

    Code Info

    Lot Number: KJ2858 Shelf Life (Expiration Date): 22 April 2023 Unique Device Identifier (UDI): +H66842200051/$$3230422KJ2858U

    Distribution

    US Nationwide distribution in the state of TX.

    Quantity

    N/A