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510(k) Data Aggregation

    K Number
    K091964
    Device Name
    CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS
    Date Cleared
    2009-09-24

    (85 days)

    Product Code
    Regulation Number
    872.6390
    Why did this record match?
    Product Code :

    JES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To remove plaque and food particles from between the teeth as part of a comprehensive dental treatment program to reduce tooth decay and to treat and prevent gingivitis.
    Device Description
    Crest Glide dental floss is a manual dental floss comprised of polytetrafluoroethylene monofilament fiber and a coating comprised of beeswax, gum arabic, water, flavor and other ingredients for color and cosmetic benefits. The floss was developed to improve ease of sliding between tight spaces to achieve effective plaque removal. Each of the materials that could come in contact with the user of this device is comprised of well-defined materials that are safe for use in the oral cavity.
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    K Number
    K964976
    Device Name
    FLOSSBRUSH WITH FLUORIDE
    Date Cleared
    1997-05-06

    (145 days)

    Product Code
    Regulation Number
    872.6390
    Why did this record match?
    Product Code :

    JES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K963746
    Device Name
    IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID
    Date Cleared
    1996-12-12

    (86 days)

    Product Code
    Regulation Number
    872.6390
    Why did this record match?
    Product Code :

    JES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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