Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K991857
    Device Name
    AIRFLOW HANDY
    Manufacturer
    ELECTRO MEDICAL SYSTEMS, INC.
    Date Cleared
    1999-10-07

    (128 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELECTRO MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AirFlow handy is a dental handpiece intended for use in the cleaning and polishing of teeth by the projection of water, air, and bicarbonate powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to clean teeth prior to dental procedures which require a clean tooth surface such as the placement of composite fillings, inlays, and laminate veneers. The device can also be used to clean the following: - implant abutments and teeth prior to treatments such as shade matching, fluoridation, and bleaching - crowns and bridges - fixed bands and brackets prior to placement on orthodontic appliances.
    Device Description
    The AirFlow handy is a hand-held device containing air and water lines, powder chamber with cap, and AirFlow nozzle. The device connects to a standard turbine tube which supplies air and water. When the AirFlow handy is connected to the turbine tube and the turbine is activated, an air/powder stream enveloped by a water spray is generated which can be directed onto the tooth surface for cleaning and polishing.
    Ask a Question
    K Number
    K965203
    Device Name
    RADX SYSTEM
    Manufacturer
    ELECTRO MEDICAL SYSTEMS, INC.
    Date Cleared
    1997-03-17

    (81 days)

    Product Code
    EHD
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELECTRO MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RAD& System digitizes and processes dental radiographs to perform longitudinal radiographic analysis using the digital subtraction technique. This technique is helpful in the detection of hard tissue changes including pathologies as well as resolution of those same pathologies.
    Device Description
    The RAD System enables the dental practitioner to take a longitudinal series of X-rays using the long-cone paralleling technique, digitize the resulting images, and perform digital subtraction analysis to detect very small changes in bone densities. The RAD System consists of a high resolution digital image scanner and the RADy software program. Also required are an IBM compatible personal computer, a long cone, and a parallel aiming system. The ability of the RADx System to create spatially registered images for comparison without the use of rigid projection geometry allows longitudinal radiographic analysis using equipment readily available to the average dental practitioner.
    Ask a Question

    Page 1 of 1