BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    X-Smart® Apex Locator Measurement cable

    DI: D100B00XSALAC1000 · Model: 1 · FORUM ENGINEERING TECHNOLOGIES (96) LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    X-Smart® Apex Locator Measurement cable
    Primary DI
    D100B00XSALAC1000
    Version / Model
    1
    Catalog Number
    B00XSALAC1000
    Company Name
    FORUM ENGINEERING TECHNOLOGIES (96) LTD.
    Labeler DUNS
    532219235
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-01-23
    Public Version
    1
    Public Version Date
    2026-02-02
    Public Version Status
    New
    Public Device Record Key
    0ef4917c-7bdf-45f8-acb4-c121c11c8f07

    Device Description

    The measurement cable is connected at one end to the device and at the other end to the File-Clip and the Lip-Clip. Apex localization is based on measurements of the impedance between the Lip-Clip and the File-Clip.

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LQY Locator, Root Apex

    GMDN Terms

    Code Name
    16355 Endodontic apex locator

    Identifiers

    Type ID
    Primary D100B00XSALAC1000