BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Inlay / Onlay Styx Kit

    DI: D8374510200 · Model: 1x Inlay / Onlay Styx, 6x White Tips · Taub Products
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Inlay / Onlay Styx Kit
    Primary DI
    D8374510200
    Version / Model
    1x Inlay / Onlay Styx, 6x White Tips
    Catalog Number
    45-1020
    Company Name
    Taub Products
    Labeler DUNS
    067488114
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-09-10
    Public Version
    3
    Public Version Date
    2020-07-07
    Public Version Status
    Update
    Public Device Record Key
    0553c2d3-d31c-4d53-a5bf-a84194fd85ef

    Device Description

    Prevents movement of the restoration during cementation. Allows for proper placement, positioning, and seating of inlays, onlays, crowns, with gentle and even distribution of pressure. Holds restoration securely during try-in, while contacts are checked with floss. Allows clear visibility of working field. Removes the need for touching the restoration with a glove. This prevents possible contamination of saliva or glove powder. Inlay/Onlay Styx are autoclavable. Tips are disposable (Single use per patient).

    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
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    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
    Yes
    Sterilization Methods
    ["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    DZN Instruments, Dental Hand

    GMDN Terms

    Code Name
    64304 Manual non-rotary dental instrument handle

    Identifiers

    Type ID
    Primary D8374510200