BEUDAMED
    Product Code: MMD FDA class 1 21 CFR 872.6865

    Toothbrush, Ionic, Battery-Powered

    Dental

    The Ionic Battery-Powered Toothbrush is a powered oral hygiene device that uses ionic technology in addition to mechanical brushing action to reduce plaque and promote dental health, with the battery providing the energy source for its operation. Classified as a Class 1 device under 21 CFR 872.6865 within the Dental specialty, it is subject to general controls only and is generally exempt from 510(k) premarket notification. It carries no implant or life-sustaining flags.

    View on FDA
    510(k)s
    2
    FEI Numbers
    37
    Registration Numbers
    37
    Unique Applicants
    2
    Years Active
    3

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    Basic Information

    Product Code
    MMD
    Device Class
    FDA class 1
    Regulation Number
    872.6865
    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
    K971639 PLUSTRON ION TOOTHBRUSH SYSTEM
    K915576 HUBUKA HYG TOOTHBRUSH

    FEI Numbers

    This FDA classification entry is associated with 37 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 37 registration numbers. Click on an entry to view related FDA registrations.