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510(k) Data Aggregation

    K Number
    K191631
    Device Name
    ZMAXX Dental Zirconia Blanks
    Manufacturer
    ZMAXX Bioceramics LLC
    Date Cleared
    2019-11-01

    (135 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZMAXX Bioceramics LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ZMAXX Dental Zirconia Blanks are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
    Device Description
    Dental Zirconia Blank is available in various specifications, which are combinations of height (12~25mm), color model (0M1/A1~ A3/B1~B4/C1~C4/D2~D4) and transparency model (T45).
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