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    K Number
    K110058
    Device Name
    BPA-FREE PIT AND FISSURE SEALANT
    Manufacturer
    NOVOCOL INC. DBA SEPTODONT AND CONFI-DENTAL PRODUC
    Date Cleared
    2011-03-31

    (80 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Type
    Abbreviated
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BPA-FREE PIT AND FISSURE SEALANT

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

    "BPA-Free Pit and Fissure Sealant" is indicated for the covering and sealing of pits and fissures in the occlusal surfaces of posterior teeth to aid in the resistance to caries in those surfaces.

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but without further context, I cannot fulfill your request. The provided text is a letter from the FDA regarding a premarket notification for a medical device (BPA-Free Pit and Fissure Sealant); it does not contain information about acceptance criteria or a study that proves the device meets those criteria.

    To help you, I would need a document that describes:

    • The specific acceptance criteria for the device (e.g., performance metrics, thresholds).
    • Details of a study conducted to evaluate the device against these criteria.
    • Information about the study's methodology, sample size, ground truth establishment, and expert involvement.
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