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510(k) Data Aggregation

    K Number
    K160049
    Device Name
    Charisma
    Manufacturer
    Heraeus Kulzer, LLC (Mitsui Chemicals Group)
    Date Cleared
    2016-11-15

    (309 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    Heraeus Kulzer, LLC (Mitsui Chemicals Group)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Direct restoration of Class I-V cavities (according to G.V. Black) Direct composite veneers Shape corrections of teeth (i.e. diastemas, congenital defects in teeth, etc.) Splinting of teeth loosened by trauma or periodontal disease Restoration of primary teeth Repairs of porcelain, composite (in combination with an adequate repair-system)
    Device Description
    Not Found
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