BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PANTOS, MODELS: PANTOS 16, AND PANTOS DG

    K Number: K031801 · Decision Sep 11, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    201
    Applicant Total
    2
    Review Days
    92

    Basic Information

    Device Name
    PANTOS, MODELS: PANTOS 16, AND PANTOS DG
    K Number
    K031801
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1800
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BLUE X IMAGING SRL
    Date Received
    June 11, 2003
    Decision Date
    September 11, 2003
    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.

    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

    DUO1 and DUO2

    FDA 510(k)
    FDA Class 2 ·Dental

    RAYSCAN a-Expert

    FDA 510(k)
    FDA Class 2 ·Dental

    Digital image scanner of dental

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor

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

    Other Clearances by BLUE X IMAGING SRL

    K Number Device Name
    K031118 INTRAOS 70