BEUDAMED
    Product Code: QJK FDA class 2 21 CFR 872.3661

    Intraoral Camera

    Dental

    The Intraoral Camera is a Class 2 dental device intended to capture the topographical characteristics of teeth or stone models, providing detailed visual information for restorative and diagnostic dentistry. It requires 510(k) clearance and is regulated under 21 CFR 872.3661 within the Dental medical specialty. The product code is QJK. The device is not an implant and is not flagged as life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    23
    Registration Numbers
    23
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    QJK
    Device Class
    FDA class 2
    Regulation Number
    872.3661
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    4

    Device Characteristics

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

    Definition

    To capture the topographical characteristics of teeth or a stone model

    FEI Numbers

    This FDA classification entry is associated with 23 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.