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510(k) Data Aggregation

    K Number
    K973541
    Device Name
    MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED
    Manufacturer
    MEDENTAL INTL.
    Date Cleared
    1997-11-25

    (68 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

    This is a chemically activated sealant that is used to seal the pit and fissures found in young teeth. This sealant assures complete cure in deep fissures.

    Device Description

    Chemically Activated Pit and Fissure Sealant

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental sealant. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot fulfill your request to describe these aspects of the device's evaluation.

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