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510(k) Data Aggregation

    K Number
    K093059
    Device Name
    SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT
    Manufacturer
    CLASSONE ORTHODONTICS, INC.
    Date Cleared
    2010-02-04

    (127 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    SeLECT Defense Dental Pit and Fissure Sealant is a BisGMA based light cured resin for the sealing of deciduous teeth and the filling of fissures in primary tooth structure.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for a dental pit and fissure sealant. It does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML medical device.

    The document primarily focuses on:

    • The FDA's determination of substantial equivalence for a physical dental device (SeLECT Defense Dental Pit and Fissure Sealant) to predicate devices.
    • Regulatory information, including product codes, regulation numbers, and compliance requirements.
    • Indications for Use for the dental sealant.

    Therefore, I cannot extract any of the requested information regarding acceptance criteria and a study proving device performance for an AI/ML device from this text.

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