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510(k) Data Aggregation

    K Number
    K133231
    Device Name
    DIGORA OPTIME
    Manufacturer
    INSTRUMENTARIUM DENTAL, PALODEX GROUP OY
    Date Cleared
    2014-03-20

    (150 days)

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

    INSTRUMENTARIUM DENTAL, PALODEX GROUP OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DIGORA® Optime imaging system is indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media. SOREDEX® DIGORA® Optime system is intended to be used only by dentist and other qualified dental professionals to process x-ray images exposed to the imaging plates from the intraoral complex of the skull.
    Device Description
    DIGORA® Optime (DXR-60) is a digital radiography system for intra oral imaging plates located in disposable bags. The system may be used with all x-ray equipment which is designed for intra oral radiography. The image is recorded on reusable imaging plate which substitutes for conventional xray film or digital sensor. The x-ray energy absorbed in the imaging plate remains stored as a latent image. When fed to the device the stored energy is released as an optical emission proportional to the stored energy when the imaging plate is stimulated pixel by a scanning laser. An optical system collects the emission for photo electronic system, which converts the emission to digital electronic signals. These signals are processed in a computer system which formats and stores the signals. Further image processing, display and achieving are carried out with auxiliary software.
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    K Number
    K093683
    Device Name
    ORTHOPANTOMOGRAPH OP300
    Manufacturer
    INSTRUMENTARIUM DENTAL, PALODEX GROUP OY
    Date Cleared
    2010-10-06

    (310 days)

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

    INSTRUMENTARIUM DENTAL, PALODEX GROUP OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Orthopantomograph® OP300 dental panoramic, cephalometric and cone beam computed tomography x-ray device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D x-ray images as well as x-ray projection images of an examined volume for the reconstruction of a 3D view. The device must only be operated and used by dentists and other legally qualified professionals.
    Device Description
    Orthopantomograph® OP300 is an extraoral source dental x-ray device, which produces conventional digital 2D panoramic, cephalometric and TMJ x-ray images as well as digital x-ray projection images taken during cone beam rotations around a patient's head. The projection images are reconstructed to be viewed in 3D by a 3D viewing software. The name Orthopantomograph® OP300 is used when the device can produce panoramic, TMJ and optionally 3D images. The name Orthoceph® OC300 is used when the cephalometric option for cephalometric x-ray images is added to the device. Furthermore, the device can be equipped with the Volumetric Tomography device (K063773).
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    K Number
    K092591
    Device Name
    ORTHOPANTOMOGRAPH OP30
    Manufacturer
    INSTRUMENTARIUM DENTAL, PALODEX GROUP OY
    Date Cleared
    2009-11-20

    (88 days)

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

    INSTRUMENTARIUM DENTAL, PALODEX GROUP OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Orthopantomograph® OP30 dental panoramic x-ray equipment is indented for dental radiographic examinations by producing digital radiographs of teeth. TM-joints and other oral structures by dentists and other legally qualified professionals.
    Device Description
    Orthopantomograph® OP30 is an extraoral source dental x-ray equipment, which produces dental panoramic and TMJ images on its digital x-rav image receptor. The technique factor settings are: 66, 70, 73 or 77 kV, 10 mA and max 10 sec.
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    K Number
    K081925
    Device Name
    SNAPSHOT
    Manufacturer
    INSTRUMENTARIUM DENTAL, PALODEX GROUP OY
    Date Cleared
    2008-09-02

    (57 days)

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

    INSTRUMENTARIUM DENTAL, PALODEX GROUP OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Snapshot is intended to be used by dentists and other qualified professionals for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.
    Device Description
    Snapshot is a digital intraoral sensor system that can be connected to a workstation PC via USB connection. The essential function and purpose of the system in a dental clinic is to capture intraoral digital dental x-ray images. The system can be used with general intraoral X-ray units. Snapshot utilizes existing designs and share parts with the predicate Sigma M sensor. The sensor is the same CMOS sensor as that of the predicate device. USB 2.0 High speed connection is used for image transfer to a PC. The basic system consists of Sensor, which is available in two sizes, Workstation software, Sensor holders and hygienic covers.
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    K Number
    K063837
    Device Name
    SIGMA M
    Manufacturer
    INSTRUMENTARIUM DENTAL, PALODEX GROUP OY
    Date Cleared
    2007-07-02

    (188 days)

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

    INSTRUMENTARIUM DENTAL, PALODEX GROUP OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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