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510(k) Data Aggregation

    K Number
    K241568
    Device Name
    CrystLCare™ PRO Biorestorative, Fluoride-Plus
    Manufacturer
    GreenMark Biomedical Inc.
    Date Cleared
    2025-01-02

    (216 days)

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

    GreenMark Biomedical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for relief of discomfort from dentin sensitivity.
    Device Description
    CrystLCare™ PRO Biorestorative, Fluoride-Plus is a flavored dental strip which contains calcium, phosphate, and fluoride which are stabilized with a modified starch. The single-use strip is topically applied to the outer surface of a tooth or teeth that are experiencing dental sensitivity. The strip dissolves in salivator elease these minerals which then will precipitate crystals that form a layer over the tooth surfaces. This physically occludes exposed dentinal tubules and enamel porosities to relieve discomfort. The modified starch helps to stabilize the calcium, phosphate, and fluoride mineral components so that they can persity into the dentinal tubules.
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    K Number
    K200601
    Device Name
    LumiCare Caries Diagnostic Rinse
    Manufacturer
    GreenMark Biomedical Inc.
    Date Cleared
    2021-03-29

    (385 days)

    Product Code
    LFC, EAQ
    Regulation Number
    872.1740
    Why did this record match?
    Applicant Name (Manufacturer) :

    GreenMark Biomedical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To aid the dental professional in visualization of carious lesions
    Device Description
    The LumiCare™ device is an oral rinse solution containing starch-based particles tagged with fluorescein. A specific volume is swished in the mouth, followed by a water rinse and air drying of teeth prior to exposure of the teeth to a blue light source with an irradiance of 450 mW/cm2 and wavelength of 450-470 nm. The clinician completes the clinical examination by observing fluorescence through light orange filter accessories, including protective eyewear, to aid the visualization of dental caries.
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