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510(k) Data Aggregation

    K Number
    K060882
    Device Name
    EXCEL BOND DC, MODEL 28-200100
    Manufacturer
    J. MORITA USA, INC.
    Date Cleared
    2006-09-01

    (154 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Excel Bond LC is intended to be used as a Self Etching Dental Adhesive.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a dental bonding agent called "Excel Bond LC" (K060882). This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone) for an AI or imaging device.

    The letter is focused on determining substantial equivalence of this dental adhesive to a legally marketed predicate device, as required for traditional medical devices, not AI/ML-enabled devices.

    Therefore, I cannot provide the requested information based on the input text.

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