BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Orthodontic retainer

    DI: 06972677870146 · Model: 014 · Modern Dental Laboratory (DG) Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Orthodontic retainer
    Primary DI
    06972677870146
    Version / Model
    014
    Company Name
    Modern Dental Laboratory (DG) Co., Ltd.
    Labeler DUNS
    551746187
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-03-09
    Public Version
    1
    Public Version Date
    2022-03-17
    Public Version Status
    New
    Public Device Record Key
    0295aeca-4ad2-4b4a-8028-a1cff070c6d8
    Distribution End Date
    2022-03-09

    Device Description

    An orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    Yes
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DYT Maintainer, Space Preformed, Orthodontic

    GMDN Terms

    Code Name
    35310 Orthodontic retainer

    Identifiers

    Type ID
    Primary 06972677870146