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510(k) Data Aggregation

    K Number
    K002620
    Device Name
    SURESMILE SYSTEM
    Manufacturer
    ORA METRIX, INC.
    Date Cleared
    2000-11-16

    (85 days)

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

    ORA METRIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SureSmile™ System is used to provide a total orthodontic care solution to orthodontists with an image acquisition and viewing technology that delivers value throughout the entire care cycle; including record collection, treatment planning, treatment delivery, monitoring of care and patient communication. This treatment objective is then used to design a custom appliance system, prescribed by the orthodontist, which is specific to each patient's needs. The result is a comprehensive care solution that addresses many problems that orthodontists face with patient care. The OraScanner is not intended for use as an operative device and is not manufactured to be sterile.
    Device Description
    The OraMetrix SureSmile System is a complete image management system capable of acquisition, transmission, archive, display and print of patient images and demographic information. Its purpose is to facilitate these operations utilizing shared data to promote the availability of information locally, remotely, and at other facilities other than which it was acquired. The process begins by using the OraScanner to obtain a three-dimensional digital image of the dentition to provide the orthodoniist a 3-D view of the teeth. These images may be integrated with other patient records to establish a three-diment objective. This treatment objective is then used to design a custom appliance system, prescribed by the orthodontist, which is specific to each patient's needs. Follow up scans using the OraScanner allow the orthodontist to precisely monitor patient progress through the entire treatment. Systems are configured to meet the customer's needs. Fully integrated systems could enable orthodontist to utilize speech recognition. The general hardware configuration of the systems may contain the following major components: -SureSmile™ OraScanner -Monitors -Central Processing Units (CPU, memory, disks, microphone, speakers) -Film and Document scanners -Digital camera -CD-ROM writer / reader -Optical Disk Libraries -RAID array -DLT Tape Libraries -9840 Tape Libraries -CD-R writer / reader -DVD-R writer / reader
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