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510(k) Data Aggregation

    K Number
    K122725
    Device Name
    TANDA PEARL, ULTRAWYTE, PEARL
    Manufacturer
    SYNERON BEAUTY
    Date Cleared
    2012-11-27

    (83 days)

    Product Code
    EEG
    Regulation Number
    872.6475
    Why did this record match?
    Product Code :

    EEG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tanda Pearl is an over-the-counter device intended for teeth bleaching. The Tanda Pearl uses low electrical current to accelerate the action of the bleaching agent to improve the whitened appearance of teeth.
    Device Description
    The Tanda Pearl device consists of a double biting mouth tray made of silicone for fitting both the upper and bottom teeth simultaneously. A bleaching agent is applied to each side of the mouth tray. The device is battery operated and turned on using a button located on the handle. Once initialized, the device delivers low amounts of electrical current (4 to 15 mA) into the bleaching medium to accelerate the teeth whitening effect caused by the bleaching medium. Once the treatment cycle has been completed, the device is automatically shut off.
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    K Number
    K110888
    Device Name
    ABSOLUTE WHITE LIGHT
    Manufacturer
    DR. FRESH, INC.
    Date Cleared
    2012-01-12

    (288 days)

    Product Code
    EEG
    Regulation Number
    872.6475
    Why did this record match?
    Product Code :

    EEG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Absolute White Light emits visible blue light in the 400 nanometer spectrum and is intended to provide a light source for bleaching teeth.
    Device Description
    The Absolute White Light is intended for use by the end consumer. The Absolute White Light is a battery operated, hand held device that contains a hun vosible light in the 400 nanometer spectrum, which can penetrate the tooth and activate the photoactive substances within the tooth yielding a minimal amount of heat. Built in safety features include automatic light shut off after two minutes and "Light Guard" that prevents light exposure to the user's eyes.
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    K Number
    K063704
    Device Name
    BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101
    Manufacturer
    BEKS INCORPORATED
    Date Cleared
    2007-02-20

    (69 days)

    Product Code
    EEG
    Regulation Number
    872.6475
    Why did this record match?
    Product Code :

    EEG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BriteWhite Teeth Whitening System is intended to emit light in the 400 nanometer spectrum to provide a light source for the bleaching of teeth.
    Device Description
    The BriteWhite Teeth Whitening System device that utilizes Light Emitting Diodes to provide a tooth whitening system, the whitening light source is a mouth piece which is placed inside the mouth, using barrier sleeves, which emits a biologically safe and effective level of blue visible light. The general wavelength for the mouth piece is 400 nanometer spectrums to provide a selected wavelength which activates the whitening gel to bleach the teeth without the aide of heat. To ensure user safety when operating the light, the system has a built in feature to eliminate any risk for the end user and professional. The light automatically shuts off after a specified period of time. Secondly, the light source in placed inside the mouth, so there is no need for safety glasses for the patient and professional. No contact with the eyes is in this area of treatment and prevents penetrations of blue wavelength and protects the vision of the patient and professional.
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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?
    Product Code :

    EEG

    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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    K Number
    K041392
    Device Name
    SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US
    Manufacturer
    CAO GROUP, INC.
    Date Cleared
    2004-11-08

    (167 days)

    Product Code
    EEG
    Regulation Number
    872.6475
    Why did this record match?
    Product Code :

    EEG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SonX 35 Ultrasonic Bleaching System is used to accelerate the action of a tooth bleaching medium by introducing energy into said medium in the form of ultrasonic vibrational impulses at a frequency cycled between 25000 and 30000 hertz, improving the appearance of teeth.
    Device Description
    The SonX 35 Ultrasonic Bleaching System is a device used in the application of dentifrice compositions for the purpose of whitening teeth. This device aids in the performance of these compositions by providing energy in the form of ultrasonic wave energy. Transducers that are fully encased in the portion of the tray external to the patient generate the ultrasonic energy at a frequency that is sinusoidally cycled between 25,000 and 30,000 hertz. Electrical pulses of a voltage not exceeding 7VDC and 300mA current are supplied to the transducers by means of a separate power source unit, which delivers the energy by means of insulated conductors attached to an appendage of the tray device. All electrical connections are external of the patient, and the transducer electrical supply is electrically isolated from the main power supply.
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    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?
    Product Code :

    EEG

    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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