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510(k) Data Aggregation

    K Number
    K040797
    Device Name
    BRITESMILE MASKING CREAM
    Manufacturer
    BRITESMILE, INC.
    Date Cleared
    2004-04-02

    (4 days)

    Product Code
    EIE
    Regulation Number
    872.6300
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRITESMILE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BriteSmile Masking Cream is intended to be used as an accessory to the BriteSmile Barrier Material to protect soft tissues during teeth-whitening procedures.
    Device Description
    The BriteSmile Masking Cream protects the lips and mucosal areas farther away from the teeth that will not come into contact with the teeth whitening gel but which may be exposed to heat from the BriteSmile lamp used to activate the bleaching gel during the teeth whitening procedure. The BriteSmile Masking Cream is a white cream with a pH of 6.5 to 7.0.
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    K Number
    K010935
    Device Name
    BRITESMILE BARRIER MATERIAL
    Manufacturer
    BRITESMILE, INC.
    Date Cleared
    2001-09-05

    (161 days)

    Product Code
    EIE
    Regulation Number
    872.6300
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRITESMILE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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