BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    PREXION3D ECLIPSE

    K Number: K122199 · Decision Apr 18, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    133
    Applicant Total
    9
    Review Days
    268

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    Basic Information

    Device Name
    PREXION3D ECLIPSE
    K Number
    K122199
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Yoshida Dental Mfg. Co., Ltd.
    Date Received
    July 24, 2012
    Decision Date
    April 18, 2013
    Product Code
    OAS
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OAS X-Ray, Tomography, Computed, Dental

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    Other Clearances by The Yoshida Dental Mfg. Co., Ltd.

    K Number Device Name
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    K120948 PREXION 3D
    K120932 OPELASER PRO II AND THE OPELASER LITE II
    K111231 PANOURA 18S
    K063622 FINECUBE DENTAL CT
    K000577 YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM INTRAORAL CAMERA
    K837491 REX PEDESTAL INTRA-ORAL X-RAY UNIT
    K828325 YOSHIDA/KAYCOR X-70 X-RAY UNIT