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510(k) Data Aggregation

    K Number
    K021383
    Device Name
    ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL
    Manufacturer
    AGION TECHNOLOGIES, LLC.
    Date Cleared
    2002-07-17

    (76 days)

    Product Code
    EFW
    Regulation Number
    872.6855
    Why did this record match?
    Applicant Name (Manufacturer) :

    AGION TECHNOLOGIES, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Zeodyne Toothbrush with AgION™ Antimicrobial is intended to remove adherent plaque and food debris from the teeth. The addition of the antimicrobial agent is to prevent the growth of bacteria on the toothbrush between brushings. The antimicrobial treatment is not intended to have any effect on the user.
    Device Description
    The Zeodyne Toothbrush with AgION antimicrobial is a manual toothbrush consisting of a shaft with synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth. The toothbrush contains an antimicrobial agent to prevent the growth of bacteria on the brush between uses, maintaining the cleanliness of the brush. The Zeodyne Toothbrush with AgION antimicrobial consists of a polymer based handle and either Nylon 6-12 or polybutylene terephthalate (PBT) bristles. The bristles contain 0.5% AgION antimicrobial.
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