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510(k) Data Aggregation

    K Number
    K012794
    Device Name
    PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT
    Manufacturer
    PRIME DENTAL MANUFACTURING, INC.
    Date Cleared
    2001-11-05

    (76 days)

    Product Code
    EBF,EBC
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT

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

    Prime-Dent® Chemical Cure Pit & Fissure Sealant (opaque and clear) is a BisGMA I Time-Dome Chomical Casin for the sealing of deciduos teeth and the filling of fissures in primary tooth structure.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) summary for "Prime-Dent Chemical Cure Pit & Fissure Sealant" (K012794) does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    The document is a letter from the FDA to the manufacturer, indicating that the device has been found substantially equivalent to a predicate device and can be marketed. It refers to the device's indications for use but does not delve into the detailed performance data that would typically be found in a study report.

    Therefore, I cannot provide the requested table and study details based on the given information.

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