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

    PANOURA 18S

    K Number: K111231 · Decision Jul 13, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    205
    Applicant Total
    9
    Review Days
    72

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    PANOURA 18S
    K Number
    K111231
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1800
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Yoshida Dental Mfg. Co., Ltd.
    Date Received
    May 2, 2011
    Decision Date
    July 13, 2011
    Product Code
    MUH
    Advisory Committee
    Dental
    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
    MUH System, X-Ray, Extraoral Source, Digital

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MUH), ordered by most recent decision date.

    SOTA Cloud Smart Sensor (1.5)

    FDA 510(k)
    FDA Class 2 ·Dental

    EzSensor HD, EzSensor UHD

    FDA 510(k)
    FDA Class 2 ·Dental

    Cocoon Solo (DX-7020s)

    FDA 510(k)
    FDA Class 2 ·Dental

    Digital X-Ray DentiMax Pro Imaging System

    FDA 510(k)
    FDA Class 2 ·Dental

    VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)

    FDA 510(k)
    FDA Class 2 ·Dental

    X Sensor (Model: IOS-A15IF, HDI-15DGF)

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

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

    K Number Device Name
    K182198 Panoura X-ERA PF/NF/MF
    K122199 PREXION3D ECLIPSE
    K120948 PREXION 3D
    K120932 OPELASER PRO II AND THE OPELASER LITE II
    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