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510(k) Data Aggregation

    K Number
    K023662
    Device Name
    PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER
    Manufacturer
    HWADONG INTERNATIONAL COMPANY LTD.
    Date Cleared
    2003-05-28

    (209 days)

    Product Code
    MCF
    Regulation Number
    872.6855
    Why did this record match?
    Product Code :

    MCF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The proSonic™ Ultraviolet Toothbrush Sanitizer is intended for use in reducing bacterial contamination that naturally accrues on toothbrushes under normal conditions of use.
    Device Description
    The proSonic Ultraviolet Toothbrush Sanitizer unit sanitizes toothbrushes hung inside the unit by reducing the amount of bacteria that accrues on them under normal conditions of use. Sanitization is accomplished via ultraviolet (UV) radiation produced by a UV lamp housed within the unit. When activated, the proSonic Ultraviolet Toothbrush Sanitizer completes an initial sanitization cycle in one (1) hour. Afterwards, a built-in timer in the unit alternately causes the UV lamp to be turned off for sixty (60) minutes and turned on for five (5) minutes in between brushing cycles. Depending on usage, the UV lamp will typically be activated for approximately one hundred-sixty five (165) minutes per day. The bulb has an effective Iife of ten thousand (10,000) hours. The sanitizer is designed so that the UV lamp can be activated only when the unit door is fully closed, and the level of ozone emitted by the sanitizer is within FDA regulatory limits. The proSonic Ultraviolet Toothbrush Sanitizer is sold with four (4) accompanying toothbrushes and a power handgrip (which converts the toothbrushes into powered toothbrushes).
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    K Number
    K021258
    Device Name
    GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER
    Manufacturer
    GERM TERMINATOR CORPORATION
    Date Cleared
    2002-05-10

    (21 days)

    Product Code
    MCF
    Regulation Number
    872.6855
    Why did this record match?
    Product Code :

    MCF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Germ Terminator Toothbrush Sanitizer is designed to sanitize up to two manual toothbrushes or two toothbrush heads between uses. The Germ Terminator Toothbrush Sanitizer is intended for home use and will be available "over the counter."
    Device Description
    The Germ Terminator uses steam heat to sanitize two manual toothbrushcs or two toothbrush heads. Water is poured into a reservoir in the device's housing and it is heated to its boiling point. Water is thereby converted into steam, which sanitizes the toothbrushes in the housing. The stcam cycle is followed by a drying cycle.
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    K Number
    K003517
    Device Name
    OTRES TOOTHBRUSH SANITIZER MODEL TB100W
    Manufacturer
    OTRES, LLC.
    Date Cleared
    2001-06-06

    (204 days)

    Product Code
    MCF
    Regulation Number
    872.6855
    Why did this record match?
    Product Code :

    MCF

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

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