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510(k) Data Aggregation

    K Number
    K042153
    Device Name
    SOUTH BEACH SMILE LIGHT WHITENING SYSTEM
    Manufacturer
    DENTOVATIONS, INC.
    Date Cleared
    2004-11-08

    (91 days)

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

    DENTOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dentovations South Beach Smile Light Whitening System is intended for use as a light source for bleaching teeth.
    Device Description
    The South Beach Smile Light Whitening System is intended for use by the consumer and sold either over the counter or by a dental professional as a yooth whitening system. The System consists of a handheld, battery operated light theat source) device, a whitening gel and preconditioning mouth wash. The Whitening Light heat source is a hand held device that contains a biologically safe and effective level of blue 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 350 -700 nm. The xenon light emits approximately 1 - 3 ° C heat agginst the tooth surface. To insure user safety when operating the light, the light has built in features that will eliminate any risk for the end user (1) light automatically shuts off after two minutes of use and (2) the light head acts a light automatouny shuts on and light from accidentally being exposed to the users eyes.
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