BEUDAMED
    FDA Registration Active 🇺🇸 United States

    X-NAV TECHNOLOGIES, LLC.

    Reg #: 3011764595 · FEI: 3011764595 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    13
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    X-NAV TECHNOLOGIES, LLC.
    Registration Number
    3011764595
    FEI Number
    3011764595
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1555 Bustard Road, Suite 75 & 110
    City
    Lansdale
    State
    PA
    ZIP
    19446
    Country
    US

    Regulatory Submissions

    510(k) Number
    K200662

    Owner / Operator

    Firm Name
    X-NAV Technologies, LLC.
    Operator Number
    10049672
    Address
    1555 Bustard Road, Suite 75
    City
    Lansdale
    State
    PA
    Postal Code
    19446
    Country
    US

    Products

    Device Name Product Code
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF
    Screw, Fixation, Intraosseous DZL
    Dental Stereotaxic Instrument PLV
    Dental Navigation System QRY

    Proprietary Names

    X-Guide FastMap FastMap FastMap Navigated Photogrammetry X-Guide Surgical Navigation System EDX Bone Screw EDX Tracker Arm IconiX AI X-Guide X-Guide IconiX AI IconiX X-Guide NXT X-Guide System X-Guide (X-Mark)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device