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510(k) Data Aggregation

    K Number
    K143290
    Device Name
    DBSWIN and VistaEasy Imaging Software
    Manufacturer
    Durr Dental AG
    Date Cleared
    2016-02-18

    (458 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Durr Dental AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DBSWIN and VistaEasy imaging software are intended for use by qualified dental professionals for windows based diagnostics. The software is a diagnostic aide for licensed radiologists, dentists and clinicians, who perform the actual diagnosis based on their training, qualification, and clinical experience, DBSWIN and VistaEasy are clinical software applications that receive images and data from various imaging sources (i.e., radiography devices and digital video capture devices) that are manufactured and distributed by Duerr Dental and Air Techniques. It is intended to acquire, display, edit (i.e., resize, adjust contrast, etc.) and distribute images using standard PC hardware. In addition, DBSWIN enables the acquisition of still images from 3rd party TWAIN compliant imaging devices (e.g., generic image devices such as scanners) and the storage and printing of clinical exam data, while VistaEasy distributes the acquired images to 3rd party TWAIN compliant PACS systems for storage and printing. DBSWIN and VistaEasy software are not intended for mammography use.
    Device Description
    DBSWIN and VistaEasy imaging software is an image management system that allows dentists to acquire, display, edit, view, store, print, and distribute medical images. DBSWIN and VistaEasy software runs on user provided PC-compatible computers and utilize previously cleared digital image capture devices for image acquisition. VistaEasy is included as part of DBSWIN. It provides additional interfaces for Third Party Software. VistaEasy can also be used by itself, as a defeatured version of DBSWIN.
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    K Number
    K150672
    Device Name
    VistaCam iX Proof
    Manufacturer
    Durr Dental AG
    Date Cleared
    2016-01-27

    (317 days)

    Product Code
    NBL
    Regulation Number
    872.1745
    Why did this record match?
    Applicant Name (Manufacturer) :

    Durr Dental AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VistaCam iX "Proof" is intended to be used as an aid in the detection and diagnosis of dental caries.
    Device Description
    The VistaCam iX "Proof" aids in the detection and diagnosis of caries. It consists of a toothbrush-sized handpiece and a "Proof" head. A USB cable connects the handpiece to a personal computer with PACS software such as DBSWIN to enable communication between a PC computer and the handpiece. After a camera cover is placed over the distal end, and an autoclave-able spacer is installed, the Handpiece is positioned over the tooth to be examined. The camera functions by illuminating the tooth surface with a light that causes the bacteria resident in carries to fluoresce. The fluoresced light is then converted into an electrical signal, sent to a computer, converted into an image (by imaging software) and presented on a monitor in multiple colors to illustrate suspected areas of decay.
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