BEUDAMED
    Product Code: QRY FDA class 2 21 CFR 872.4120

    Dental Navigation System

    Dental

    The Dental Navigation System is a real-time guidance device intended to assist clinicians by displaying the orientation and location of a dental instrument relative to the patient's anatomy during general dentistry procedures, enabling more accurate and controlled instrument placement. It combines imaging and software to provide intraoperative spatial guidance. Classified as FDA Class 2 under regulation 872.4120, it requires 510(k) clearance and falls under the Dental specialty. The device is not an implant and not life-sustaining.

    View on FDA
    510(k)s
    4
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    2
    Years Active
    2

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    Basic Information

    Product Code
    QRY
    Device Class
    FDA class 2
    Regulation Number
    872.4120
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Intended to provide real-time guidance on the orientation and location of the dental instrument relative to the patient's anatomy for general dentistry procedures.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 4 510(k) clearances via K numbers.

    K Number Device Name
    K232148 X-Guide Surgical Navigation System
    K222750 Yomi Robotic System
    K222049 Yomi Robotic System
    K211701 X-Guide® Surgical Navigation System

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.