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510(k) Data Aggregation

    K Number
    K991909
    Device Name
    DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT
    Manufacturer
    DENTSPLY INTL.
    Date Cleared
    1999-08-20

    (74 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K942031,K951296,K982564
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    preventive sealing of pits and fissures in the primary and secondary dentition in combination with the acid-etch technique.

    Device Description

    DELTON® FS WITH FLUORIDE PIT & FISSURE SEALANT is a visible light-cured, radiopaque, resinous material designed for application to the occlusal surfaces of caries-susceptible posterior teeth to seal irregularities and prevent ingress of oral fluids, food and debris. DELTON® FS WITH FLUORIDE PIT & FISSURE SEALANT also includes DELTON® Etchant Gel, a DENTSPLY legally marketed device (K942031). The sealant is dispensed to the acid-etched tooth via an individually filled cartridge inserted into the applicator handle (Direct Delivery System).

    AI/ML Overview

    This looks like a 510(k) premarket notification for a dental sealant, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and AI-specific metrics (like MRMC studies, training/test set sizes, expert ground truth, etc.) is not applicable here because:

    • No AI/ML Component: The device, DELTON® FS WITH FLUORIDE PIT & FISSURE SEALANT, is a physical material used for sealing teeth. It does not involve any artificial intelligence or machine learning components.
    • Predicate Device Comparison: The submission primarily relies on demonstrating substantial equivalence to previously marketed predicate devices (DELTON® Plus Pit & Fissure Sealant and DELTON® FS Direct Delivery System) based on similar composition, intended use, and physical properties.
    • Performance Data Type: The "performance data" mentioned in the document refers to physical property comparisons of the sealant material, not diagnostic or predictive performance metrics typically associated with AI.

    Therefore, I cannot provide the requested table and study details as they pertain to AI/ML device evaluations. The provided document details a different type of medical device submission.

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