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510(k) Data Aggregation

    K Number
    K102252
    Device Name
    DMP PIT & FISSURE SEALANT
    Manufacturer
    DMP LTD
    Date Cleared
    2010-12-03

    (115 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
    • Pits and fissures of molars and premolars
    • Fissures on the lingual sides of anterior teeth
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is an FDA 510(k) clearance letter for a dental pit and fissure sealant, which confirms that the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements but does not include details on performance studies, acceptance criteria, or ground truth establishment.

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