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510(k) Data Aggregation

    K Number
    K011822
    Device Name
    PIT AND FISSURE CHEMICAL CURING SEALANT
    Manufacturer
    RITE-DENT MANUFACTURING CORP.
    Date Cleared
    2001-08-07

    (57 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 ad fissures found in primary and secondary dentition in combination with the acid etching technique. This sealant assures complete cure in deep fissures.

    Device Description

    Pit and Fissure Sealant

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a dental pit and fissure sealant. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or any other details about a study. This document is solely an FDA clearance letter confirming substantial equivalence to a predicate device.

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