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510(k) Data Aggregation

    K Number
    K063626
    Device Name
    DURAFLEX
    Manufacturer
    COSMETIC DENTAL MATERIALS INC
    Date Cleared
    2007-02-08

    (64 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    COSMETIC DENTAL MATERIALS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DuraFlex thermoplastic resin is used for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.
    Device Description
    The DuraFlex material is a thermoplastic resin that is used to fabricate dental prostheses. The resin is used in an injection molding or pressing device to fabricate the prostheses.
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    K Number
    K052040
    Device Name
    QUICKSMILE
    Manufacturer
    COSMETIC DENTAL MATERIALS INC
    Date Cleared
    2005-10-18

    (82 days)

    Product Code
    EEG
    Regulation Number
    872.6475
    Why did this record match?
    Applicant Name (Manufacturer) :

    COSMETIC DENTAL MATERIALS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The QuickSmile light is intended to emit light in the 600-700 nanometer spectrum to provide a heat source for bleaching teeth.
    Device Description
    The QuickSmile light is intended for use by a dental professional as a tooth whitening system. The whitening light heat source is a stand alone unit which emits a biologically safe and effective level of red visible light, which can penetrate the tooth and activate the photoactive substances within the tooth yielding a minimal amount of heat. The general wavelength is 600-700 nanometers. The LED light emits approximately 1º-3º C heat against the tooth surface. To ensure user safety when operating the light, the light has built in features to eliminate any risk for the end user and dental professional. First, the light automatically shuts off after a specified period of time designated by the dental professional. Secondly, the light is supplied with specially designed safety glasses for the patient and dental professional that stop the penetration of the red/orange wavelength and protect the vision of the patient and dental professional.
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