BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Visalys Temp

    DI: E217138501 · Model: 13850 · Kettenbach GmbH & Co. KG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Visalys Temp
    Primary DI
    E217138501
    Version / Model
    13850
    Catalog Number
    13850
    Company Name
    Kettenbach GmbH & Co. KG
    Labeler DUNS
    316803246
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-09-10
    Public Version
    1
    Public Version Date
    2025-09-18
    Public Version Status
    New
    Public Device Record Key
    9f570407-d282-4448-886f-9050cb9d969d

    Device Description

    Visalys Temp One:One Bright [B1-A1] Normal pack

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EBG Crown And Bridge, Temporary, Resin

    GMDN Terms

    Code Name
    31783 Temporary dental crown/bridge

    Identifiers

    Type ID
    Primary E217138501

    Premarket Submissions

    Submission Number Supplement Number
    K122039 000