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

    PREXION 3D

    K Number: K120948 · Decision Dec 21, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    133
    Applicant Total
    9
    Review Days
    267

    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
    PREXION 3D
    K Number
    K120948
    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
    March 29, 2012
    Decision Date
    December 21, 2012
    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

    Similar 510(k) Clearances

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

    Dental X-ray System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Dental Cone Beam Computed Tomography System

    FDA 510(k)
    FDA Class 2 ·Radiology

    medXion NEXUS

    FDA 510(k)
    FDA Class 2 ·Radiology

    RCT800

    FDA 510(k)
    FDA Class 2 ·Radiology

    Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)

    FDA 510(k)
    FDA Class 2 ·Radiology

    myray ProXIma X6

    FDA 510(k)
    FDA Class 2 ·Radiology
    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
    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