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510(k) Data Aggregation

    K Number
    K190112
    Device Name
    Non-Sterile Zirconia Block
    Manufacturer
    Fine Advanced Compound Co., Ltd
    Date Cleared
    2019-12-20

    (331 days)

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

    Fine Advanced Compound Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Non-Sterile Zirconia Block (Model: Finebase, Montblanc, Trione C, Trione HT+) are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
    Device Description
    Non-Sterile Zirconia Block (Model name: Finebase, Montblanc, Trione HT, Trione C, Trione HT+) is a manufacture unit that is cut, processed and sintered by CAD/CAM system of the computers designed for production of dental restoration.
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