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510(k) Data Aggregation

    K Number
    K050959
    Device Name
    DELTON ILLUMINATING PIT AND FISSURE SEALING
    Manufacturer
    DENTSPLY INTERNATIONAL
    Date Cleared
    2005-05-11

    (23 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K951296
    Predicate For
    K101245
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    DELTON® Illuminating Pit and Fissure Sealant is indicated for preventive sealing of pits and DELT ON® Inummanding in and secondary dentition in combination with the acid-etch technique.

    Device Description

    The DELTON® Illuminating Pit & Fissure Sealant is a pit and fissure sealant containing releasable fluoride. The sealant contains a dye that is not visible in ordinary light but fluoresces a blue-white upon exposure to UVA light. Fluorescence provides contrast with natural dentition for margin inspection.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria for the DELTON® Illuminating Pit & Fissure Sealant. The document is a 510(k) summary and an FDA clearance letter, which describes the device, its intended use, and its substantial equivalence to a predicate device but does not contain detailed study results or acceptance criteria tables. Therefore, I cannot generate the requested table and information.

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