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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
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a dental disc, outlining its regulatory status and intended use. It does not include details on performance studies, sample sizes, ground truth establishment, or expert qualifications.

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