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    K Number
    K011908
    Device Name
    OPTIBOND SOLO PLUS 3
    Manufacturer
    KERR DENTAL MATERIALS CENTER
    Date Cleared
    2001-09-06

    (79 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OPTIBOND SOLO PLUS 3

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

    OptiBond Solo Plus 3 is a multi-purpose bonding agent designed to be used in direct situations, i.e., composite to enamel and/or dentin, composite repair, composite to metal, amalgam sealing, bonding composite core build-up materials, pit and fissure sealant, and for indirect situations, i.e., veneers, onlays, inlays, crowns, and post cementation.

    Device Description

    The device is a multi-purpose bonding agent designed to be used in direct situations including composite to enamel and/or dentin, composite repair, composite to metal, amalgam sealing, bonding composite core build-up materials and fissure sealant, and for indirect situations including veneers, onlays, inlays, crowns, and post cementation.

    AI/ML Overview

    This is a medical device application for a pit and fissure sealant (OptiBond Solo Plus 3), not an AI/ML device. Therefore, the provided text does not contain information about acceptance criteria, study details, ground truth, or sample sizes related to AI/ML device performance. The document is a 510(k) summary for a traditional medical device demonstrating substantial equivalence to a predicate device.

    To answer your request, if this were an AI/ML device, the following information would typically be required but is not available in the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    MetricAcceptance CriteriaReported Device Performance
    (Not Applicable - No AI/ML device)(Not Applicable)(Not Applicable)

    2. Sample Size for Test Set and Data Provenance

    • Sample Size for Test Set: Not applicable.
    • Data Provenance: Not applicable.

    3. Number of Experts and Qualifications for Ground Truth of Test Set

    • Number of Experts: Not applicable.
    • Qualifications of Experts: Not applicable.

    4. Adjudication Method for Test Set

    • Adjudication Method: Not applicable.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    • Was an MRMC study done? Not applicable.
    • Effect size of human reader improvement with AI vs. without AI assistance: Not applicable.

    6. Standalone Performance Study

    • Was a standalone study done? Not applicable.

    7. Type of Ground Truth Used

    • Type of Ground Truth: Not applicable.

    8. Sample Size for Training Set

    • Sample Size for Training Set: Not applicable.

    9. How Ground Truth for Training Set Was Established

    • How Ground Truth for Training Set was established: Not applicable.
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