BEUDAMED
    Product Code: ECT FDA class 1 21 CFR 872.4565

    Driver, Band, Orthodontic

    Dental

    The Orthodontic Band Driver is a dental hand instrument used in conjunction with a band pusher to drive and fully seat an orthodontic band to its final position on a tooth using mallet-assisted pressure or direct hand force. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is ECT and the applicable regulation is 21 CFR 872.4565, under the Dental medical specialty.

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    510(k)s
    0
    FEI Numbers
    27
    Registration Numbers
    27
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    ECT
    Device Class
    FDA class 1
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 27 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 27 registration numbers. Click on an entry to view related FDA registrations.