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510(k) Data Aggregation

    K Number
    K981861
    Device Name
    LINER 1:HARD RELINE LIQUID
    Manufacturer
    HARRY J. BOSWORTH CO.
    Date Cleared
    1998-10-01

    (141 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Hard Reline Liquid is used as a hard liner and repair material for removable dentures.

    Device Description

    LINER I: HARD RELINE LIQUID

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental product called "Liner 1: Hard Reline Liquid." It confirms the device's substantial equivalence to a legally marketed predicate device.

    The letter does not contain any information about acceptance criteria, a study proving device performance, sample sizes, data provenance, expert qualifications, ground truth establishment, or any details related to AI performance or comparative effectiveness studies. Therefore, I cannot fulfill your request to describe these aspects based on the given input.

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