BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Plasdent

    DI: D832ATS2X1 · Model: ATS-2X · PLASDENT CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    20

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    Basic Information

    Brand Name
    Plasdent
    Primary DI
    D832ATS2X1
    Version / Model
    ATS-2X
    Catalog Number
    ATS-2X
    Company Name
    PLASDENT CORPORATION
    Labeler DUNS
    190377184
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    20
    Record Status
    Published
    Publish Date
    2022-01-27
    Public Version
    2
    Public Version Date
    2023-04-04
    Public Version Status
    Update
    Public Device Record Key
    3ef67c34-da53-4d6b-836a-e0688fd3dfda

    Device Description

    Aligner Tray Seaters, Dark Blue

    Device Characteristics

    Single Use
    Yes
    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
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NRD Unit, Operative Dental, Accessories

    GMDN Terms

    Code Name
    63676 Orthodontic aligner/retainer seater, single-use

    Identifiers

    Type ID
    Unit of Use D832ATS2X0
    Primary D832ATS2X1