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510(k) Data Aggregation

    K Number
    K993223
    Device Name
    RAPICURE 200 (CURING AND WHITENING LIGHT)
    Manufacturer
    Date Cleared
    1999-11-01

    (35 days)

    Product Code
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIPHOTONIX, LC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is intended for use: 1. As a source of illumination for curing dental restorative materials, 2. Assisting in the whitening process in a dental office.
    Device Description
    The RapiCure 2000 is a high pressure mercury light source filtered and transmitted through an optical fiber for the curing of composite resins, as an aid in the whitening of teeth, and for other dental purposes. The device emits filtered light in the range from 400 to 500 nm. It accepts voltages from 100-230 VAC.
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