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510(k) Data Aggregation

    K Number
    K250714

    Validate with FDA (Live)

    Device Name
    FluoroDose Varnish
    Manufacturer
    Centrix, Inc.
    Date Cleared
    2025-11-21

    (256 days)

    Product Code
    LBH
    Regulation Number
    872.3260
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K040098,K131376,K231338
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Treatment of dental hypersensitivity and reduction of post-operative sensitivity.

    Device Description

    The FluoroDose Varnish is a fluoride varnish available in mint flavor. FluoroDose varnish is sold in single-use Lollitrays, containing a 0.3ml dose and a Benda Brush applicator brush. The device is not sold as sterile and does not require sterilization prior to use. The product is offered in a 2.1% sodium fluoride variation and a 5% sodium fluoride variation. The device is used as a dentin desensitizer to be used by healthcare professionals including dentists and dental hygienists.

    AI/ML Overview

    N/A

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