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510(k) Data Aggregation

    K Number
    K983305
    Device Name
    SCI-PHARM DESENSITIZING VARNISH
    Manufacturer
    SCIENTIFIC PHARMACEUTICALS, INC.
    Date Cleared
    1998-12-17

    (87 days)

    Product Code
    LBH
    Regulation Number
    872.3260
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SCI-PHARM DESENSITIZING VARNISH

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

    Seals dentin tubulae in order to reduce post-operative sensitivity; will also improve the quality and functionality of restorations when used in conjunction with dental restoratives and cernents.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets acceptance criteria. The text provided is a 510(k) clearance letter from the FDA for a device called "Sci-Pharm Desensitizing Varnish." This letter indicates that the device has been found substantially equivalent to a predicate device and can be marketed. It does not contain details about performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

    Therefore, I cannot fulfill your request for the detailed table and study information.

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