Quality Management System

X-Nav Technologies is committed to delivering innovative solutions for the dental market through high-quality products and services.

Development, testing, manufacturing, marketing and distribution processes are compliant with relevant regulatory and quality standards set forth by local and global agencies.  

X-Nav Technologies employs rigorous compliance programs to ensure we deliver quality products and services to our customers. 

The company has received clearance to market and sell the X-Guide Dynamic 3D Navigation System to dental clinicians in the United States, Canada, Australia, the European Community, and many more countries. For a full list, please visit our International page.

    Global Regulatory Representatives

    UNITED STATES
    X-Nav Technologies, LLC.
    1555 Bustard Road, Suite 75
    Lansdale, PA 19446
    Telephone: 267-436-0420

    AUSTRALIA – Sponsor
    Emergo Australia
    201 Sussex Street
    Darling Park, Tower II,
    Level 20

    Sydney, NSW, 2000
    Australia

    Telephone: +61-2-9006-1662

    EUROPE – Authorized Representitive
    Emergo Europe
    Prinsessegracht 20
    2514 AP The Hague
    The Netherlands
    Telephone: +31-70-364-0181

    X-Nav Technologies, LLC Quality Management System (QMS) has been certified to be compliant with the requirements of ISO 13485:2016 and the applicable MDSAP country regulations, by a reputable registrar. Additionally, X- Nav products have undergone safety certification testing to IEC 60601-1 main standard and applicable collateral standards, including IS EN 62471-1.

    ISO 13485:2016 / MDSAP Certificate

    X-Nav is proud to demonstrate our commitment to quality and best practices in all that we do -

    Business, Regulation, Product, and Services.