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510(k) Data Aggregation

    K Number
    K980106
    Device Name
    THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES
    Manufacturer
    Date Cleared
    1998-08-03

    (203 days)

    Product Code
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROMA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This dental operating unit system is intended for use by professionally trained demists and their supervised dental hygienists and assistants to support their general, nonsurgical dental diagnostic and restorative procedures performed within contemporary standards of dental patient care. When properly used and cared for, the system is safe and effective and meets advertised claims. When equipped with isolated patient water (bottle) system that is properly installed and cared for, it has been shown to reduce the number of microbes in the water dispensed.
    Device Description
    Dental Operating Unit
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