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510(k) Data Aggregation

    K Number
    K984415
    Device Name
    S.S. WHITE TECHNOLOGIES, MODELS 6500-D,6500-E, AND 6500-F
    Date Cleared
    1999-09-29

    (293 days)

    Product Code
    Regulation Number
    872.6080
    Why did this record match?
    Applicant Name (Manufacturer) :

    S.S. WHITE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The S.S. White Technologies 6500 Series Air Abrasion Devices are used for cavity preparation in Classes I, II, III, IV, and V. The uses include removal of tooth structure and restorative dental materials, and site preparation for pit and fissure sealant therapy and bonding of porcelain and ceramic. They are also used for restoration prophylaxis.
    Device Description
    The 6500-D, 6500-E, and 6500-F are pneumatic devices which combine pressurized air and abrasive powder (e.g. aluminum oxide or sodium bicarbonate) to produce a high velocity stream of particles to perform dental restorative procedures. The abrasive particulate is delivered via a small handpiece which is approximately the size of a dental drill handpiece. The systems are designed for ease of service and maintenance with a readily accessible refillable container for the particulate supply.
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