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510(k) Data Aggregation

    K Number
    K123514
    Device Name
    CLEARPATH ALIGNER
    Date Cleared
    2013-11-01

    (352 days)

    Product Code
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    QSERVE AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ClearPath Aligner is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition (i.e. all second molars). The ClearPath Aligner is intended for minor anterior tooth movement by way of continuous gentle force.
    Device Description
    ClearPath Orthodontics uses clear, thin, thermoformed plastic material for the manufacture of its ClearPath Aligner. The aligners are provided non-sterile and are customized for each patient according to the molds provided by the treating dentist or orthodontist. Depending on the patient need and the treatment plan, a series of aligners may be used. The duration of use for each aligner is 14 days and it is to be worn except during meals.
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    K Number
    K110246
    Device Name
    MEDISIZE RED AND MEDISIZE BLUE
    Date Cleared
    2011-11-04

    (281 days)

    Product Code
    Regulation Number
    868.5260
    Why did this record match?
    Applicant Name (Manufacturer) :

    QSERVE AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1 The Medisize Red devices with catheter mount are breathing circuit bacterial/viral filters, which are intended to remove microbiological and particulate matter from the gases in the breathing circuit. 2 The Medisize Blue devices with catheter mount are Filter/HME's. These devices are intended to remove microbiological and particulate matter from the gases in the breathing circuit and at the same time the device is intended to be positioned over a tracheotomy or tracheal tube to warm and humidify by passive means gases breathed in by patient during anesthesia and ventilator care.
    Device Description
    Not Found
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