BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    OSUNG MND

    DI: 08800075626318 · Model: BWSUS1 · OSUNG MND Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    OSUNG MND
    Primary DI
    08800075626318
    Version / Model
    BWSUS1
    Company Name
    OSUNG MND Co., Ltd.
    Labeler DUNS
    688207479
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-02-23
    Public Version
    2
    Public Version Date
    2025-11-03
    Public Version Status
    Update
    Public Device Record Key
    f1c23c18-73f6-499d-ac50-ce5940407d81
    Distribution End Date
    2025-10-31

    Device Description

    A slab, tray, or well, or palette with wells intended to be used as a surface for mixing inactive dental component materials chairside to produce a functional dental restorative/impression material that is immediately applied to the oral cavity/teeth of the patient, or extraorally to a dental restoration, during a dental procedure. It is typically made of plastic or glass and the user will ordinarily mix the component materials on or in the device by hand (e.g., with a spatula or brush). This is a reusable device.

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    NDP Accessories, Implant, Dental, Endosseous

    GMDN Terms

    Code Name
    63877 Dental material mixing surface, chairside, reusable

    Identifiers

    Type ID
    Primary 08800075626318