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510(k) Data Aggregation

    K Number
    K234085
    Device Name
    LUNE™ PureHygiene
    Manufacturer
    Enamel Pure
    Date Cleared
    2024-03-25

    (94 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Enamel Pure

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Enamel Pure LUNE PureHygiene is indicated for the following in dental hard tissue: • Reduction of bacterial level (decontamination)
    Device Description
    The subject LUNE PureHygiene is a mobile, cart-based dental treatment system comprised of a base console, a pneumatic footswitch, and handpieces that uses a pulsed CO2 laser energy to reduce/remove plaque and embedded carbonate from dental enamel.
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