BEUDAMED
    Product Code: QJJ FDA class 1 21 CFR 872.5410

    Indirect Bonding Tray

    Dental

    The Indirect Bonding Tray is a Class 1 dental device consisting of a tray or splint designed to enable the simultaneous bonding of multiple orthodontic brackets to tooth surfaces, improving the efficiency and precision of bracket placement during orthodontic treatment. It is exempt from 510(k) premarket notification and is regulated under 21 CFR 872.5410 within the Dental medical specialty. The product code is QJJ. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    39
    Registration Numbers
    39
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    QJJ
    Device Class
    FDA class 1
    Regulation Number
    872.5410
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    4

    Device Characteristics

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

    Definition

    A tray or splint to enable bonding of multiple orthodontic brackets to tooth surfaces.

    FEI Numbers

    This FDA classification entry is associated with 39 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 39 registration numbers. Click on an entry to view related FDA registrations.