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510(k) Data Aggregation

    K Number
    K101875
    Device Name
    BK BLANK MODEL 20,40,65,90
    Manufacturer
    BK MEDENT CO., LTD.
    Date Cleared
    2010-08-23

    (48 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    BK BLANK is indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; namely crowns and bridges.

    Device Description

    Not Found

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a dental device called "BK Blank 20, 40, 65, 90." This document primarily focuses on the regulatory clearance process, stating that the device is substantially equivalent to legally marketed predicate devices for its intended use as a substructure for porcelain-fused ceramic fixed dental restorations (crowns and bridges).

    However, the provided text does not contain any information about:

    • Acceptance criteria or reported device performance
    • Details of any study conducted to meet acceptance criteria
    • Sample sizes for test or training sets
    • Data provenance
    • Number or qualifications of experts
    • Adjudication methods
    • Multi-reader multi-case (MRMC) studies
    • Standalone algorithm performance
    • Type of ground truth used

    Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about the study, as this information is not present in the given text.

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