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510(k) Data Aggregation

    K Number
    K110642
    Device Name
    SILJETR SYSTEM
    Manufacturer
    DANVILLE MATERIALS INC.
    Date Cleared
    2011-05-27

    (81 days)

    Product Code
    EBF,KLE,KOJ
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K101402
    Why did this record match?
    Reference Devices :

    K101402

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Silver system is a system used to The and repair cerainic and intettil oond Vestoration S dental

    Device Description

    SilJet System

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria. The document is primarily a letter from the FDA regarding a 510(k) premarket notification for the "SilJet System" device, indicating substantial equivalence to predicate devices. It discusses regulatory requirements but does not include:

    • A table of acceptance criteria and reported device performance.
    • Details about sample sizes, data provenance, or ground truth establishment for test or training sets.
    • Information on expert qualifications, adjudication methods, or MRMC studies.
    • Results from standalone algorithm performance tests.

    The document states the "Indications for Use" for the SilJet System, which is "a system used to repair ceramic and indirectly bonded dental restorations." However, it does not provide the specific performance metrics or study details to support this indication.

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