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510(k) Data Aggregation

    K Number
    K181331
    Device Name
    JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White
    Manufacturer
    Juvora, Ltd.
    Date Cleared
    2018-12-21

    (214 days)

    Product Code
    EBI, EBF, EBG
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    Juvora, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The JUVORA™ Oyster White Dental Disc is a thermoplastic dental disc. They are intended to be used for the manufacture of: i) full and partial removable dentures and implant overdentures. ii) copings, substructures (cemented or uncemented), frameworks for permanent and transitional anterior or posterior crowns and bridgework.
    Device Description
    The JUVORA™ Oyster White Dental Disc is a thermoplastic dental disc.
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