BEUDAMED
    Product Code: ECM FDA class 1 21 CFR 872.5410

    Band, Preformed, Orthodontic

    Dental

    The Preformed Orthodontic Band is a prefabricated metal ring in a range of standard sizes that is fitted around a molar or premolar tooth and cemented in place to serve as an anchor for orthodontic attachments and arch wires. 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 ECM and the applicable regulation is 21 CFR 872.5410, under the Dental medical specialty.

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    510(k)s
    2
    FEI Numbers
    85
    Registration Numbers
    85
    Unique Applicants
    2
    Years Active
    6

    Basic Information

    Product Code
    ECM
    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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K925163 MICODOSE CHLORHEXIPREP
    K872471 TITANE SL DENTAL BURR

    FEI Numbers

    This FDA classification entry is associated with 85 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 85 registration numbers. Click on an entry to view related FDA registrations.