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510(k) Data Aggregation

    K Number
    K180252
    Device Name
    Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank
    Manufacturer
    Crown Porcelain Dental Technology Co., Ltd.
    Date Cleared
    2018-04-24

    (84 days)

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

    Crown Porcelain Dental Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
    Device Description
    Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank are available in discs shape, and in various specifications, which are combinations of height (10~25mm), color model (0M1/A1~A4/B1~B4/C1~C4/D2~D4) and transparency model (T41/T45/T49/TR).
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