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

    MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM

    K Number: K093453 · Decision Nov 30, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    41
    Applicant Total
    13
    Review Days
    25

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    Basic Information

    Device Name
    MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM
    K Number
    K093453
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.1810
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Schick Technologies, Inc.
    Date Received
    November 5, 2009
    Decision Date
    November 30, 2009
    Product Code
    EAP
    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
    EAP Unit, X-Ray, Intraoral

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