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510(k) Data Aggregation

    K Number
    K092833
    Device Name
    ENDOMAX CORDLESS ENDODONTIC HANDPIECE
    Manufacturer
    DENTAMERICA
    Date Cleared
    2010-01-07

    (114 days)

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

    DENTAMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Endomax™ is a cordless handpiece used primarily for root canal enlargement. This application area extends to endodontic procedures using a root canal instrument which is intended by the manufacturer for use in the mechanical and rotary preparation of root canals.
    Device Description
    The Endomax" Cordless Endodontic Handpiece has a number of substantially equivalent (SE) predicate devices. These predicate devices use the same technological methods to perform mechanical and rotary preparation of root canals with a cordless handpiece. A modular electrical system consisting of a drive handpiece, a rechargeable battery, contraangle head and a charging station are the main components of the predicate devices. The materials used in this device are composed of brass, silicon and Type II plastic as in the substantially equivalent devices.
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    K Number
    K060640
    Device Name
    DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM
    Manufacturer
    DENTAMERICA
    Date Cleared
    2006-04-24

    (45 days)

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

    DENTAMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Digirex™ Digital Dental Radiography System replaces the traditional film approach to x-ray imaging. A digital sensor rather than film is used to capture x-rays from an external source and produce digital images of a patient's mouth. The digital sensor and the USB controller allow the images to be transferred to a computer for analysis, archiving and electronic transmission.
    Device Description
    The Digirex™ Digital Dental Radiography System replaces the traditional film approach to x-ray imaging. A digital sensor rather than film is used to capture x-rays from an external source and produce digital images of a patient's mouth. The digital sensor and the USB controller allow the images to be transferred to a computer for analysis, archiving and electronic transmission.
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    K Number
    K954820
    Device Name
    SCALEX 800
    Manufacturer
    DENTAMERICA
    Date Cleared
    1996-01-18

    (90 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTAMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K955759
    Device Name
    LITEX 680
    Manufacturer
    DENTAMERICA
    Date Cleared
    1996-01-02

    (15 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTAMERICA

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