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510(k) Data Aggregation

    K Number
    K210115
    Device Name
    FiteBac CC OrthoSeal
    Manufacturer
    Largent Health, LLC
    Date Cleared
    2021-07-29

    (191 days)

    Product Code
    DYH, FIT
    Regulation Number
    872.3750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Largent Health, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FiteBac® CC OrthoSeal with K18 QAMS is a light cure primer intended to prepare the tooth surface prior to bonding orthodontic appliances to etched enamel.
    Device Description
    The FiteBac® CC OrthoSeal is a 5% K18 Quaternary Ammonium Methacrylate (QAMS) functionalized, light cured orthodontic sealant used to prepare etched enamel for orthodontic bonding.
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    K Number
    K200614
    Device Name
    FiteBac Antimicrobial Cavity Cleanser
    Manufacturer
    Largent Health, LLC
    Date Cleared
    2020-06-25

    (108 days)

    Product Code
    LBH
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    Largent Health, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FiteBac® Antimicrobial Cavity Cleanser with 2% K21 QAS is an antimicrobial aqueous ethanolic solution intended for cleansing and moistening/re-wetting of cavity preparations.
    Device Description
    The FiteBac® Antimicrobial Cavity Cleanser is an antimicrobial 2% K21 Quaternary Ammonium Silanefunctionalized (QAS) aqueous ethanolic solution intended for cleansing and moistening/re-wetting of prepared dental surfaces. It is recommended for use upon completion of tooth preparation or etching, prior to sealing dentinal tubules. FiteBac® Antimicrobial Cavity Cleanser acts on the microorganisms in the table below, and not only removes debris in carious lesion preparations but can penetrate exposed dentin tubules allowing restorative adhesives to tightly bind to the prepared dentin surface.
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    K Number
    K190271
    Device Name
    FiteBac Cavity Cleanser
    Manufacturer
    Largent Health, LLC
    Date Cleared
    2020-01-23

    (349 days)

    Product Code
    LBH
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    Largent Health, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FiteBac® Cavity Cleanser is a 2% K21 QAS aqueous ethanolic solution intended for cleansing and moistening/re-wetting of cavity preparations.
    Device Description
    The FiteBac® Cavity Cleanser is a 2% K21 Quaternary Ammonium Silane-functionalized (QAS) aqueous ethanolic solution intended for cleansing and moistening/re-wetting of prepared dental surfaces. It is recommended for use upon completion of tooth preparation or etching, prior to sealing dentinal tubules. Research has shown that FiteBac® Cavity Cleanser can not only remove debris in carious lesion preparations but can penetrate exposed dentin tubules allowing restorative adhesives to tightly bind to the prepared dentin surface. Clinical studies have not been conducted to demonstrate that this device results in improved clinical outcomes.
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