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510(k) Data Aggregation

    K Number
    K080076
    Device Name
    RX DC X-RAY UNIT
    Manufacturer
    CEFLA S.C.R.L.
    Date Cleared
    2008-03-14

    (63 days)

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

    CEFLA S.C.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This x-ray unit is designed for use in the dental surgery to make endo-oral x-rays for diagnostic purposes. This equipment can be used to produce traditional x-rays developed using chemicals or, alternatively, it can be used with digital x-ray sensors.
    Device Description
    Not Found
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    K Number
    K062897
    Device Name
    C-U2
    Manufacturer
    CEFLA S.C.R.L.
    Date Cleared
    2006-12-14

    (78 days)

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

    CEFLA S.C.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The C-U2 is a digital intraoral camera system specifically designated for easy intraoral dental examinations, with an extremely lightweight handpiece, automatic brightness adjustment and fixed focus. It is conceived to assist the dentist during the day-by-day communications with the patient, to explain the treatment and to improve the patient's awareness.
    Device Description
    The C-U2 is a digital intraoral camera system specifically designated for easy intraoral dental examinations, with an extremely lightweight handpiece, automatic brightness adjustment and fixed focus.
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    K Number
    K061114
    Device Name
    WDS, SIZE 2 AND SIZE 2
    Manufacturer
    CEFLA S.C.R.L.
    Date Cleared
    2006-06-06

    (46 days)

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

    CEFLA S.C.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    the wireless digital RX sensor is intended to capture an intraoral digital RX image, when exposed to X-Rays, for diagnostic purposes. The process is automatic and continues transmitting to a Personal Computer the digital image by wireless Bluetooth connection.
    Device Description
    WDS is a wireless digital X-ray sensor for intraoral radiography.
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