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510(k) Data Aggregation

    K Number
    K062410
    Device Name
    CLEARFIL ESTHETIC CEMENT & DC BOND
    Manufacturer
    KURARAY MEDICAL INC.
    Date Cleared
    2006-09-26

    (40 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K032455,K012735,K043177
    Predicate For
    K081583,K111982,K150704
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
      1. Cementation of crowns, bridges, inlays and onlays made of porcelain, ceramic, hybrid ceramics, composite resin or metal
      1. Cementation of veneers
      1. Cementation of adhesion bridges
      1. Cementation of metal cores, resin cores, metal posts or glass-fiber posts
    Device Description

    CLEARFIL ESTHETIC CEMENT & DC BOND

    AI/ML Overview

    The provided text is a 510(k) Summary for a dental cement product, CLEARFIL ESTHETIC CEMENT & DC BOND. It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.

    Instead, the document focuses on:

    • Identification of the device and applicant.
    • Identification of predicate devices used to establish substantial equivalence.
    • Indications for Use of the device.
    • FDA's 510(k) clearance letter, stating that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text. The document is primarily a regulatory filing for market clearance, not a performance study report.

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