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

    COMPUTED ORAL RADIOLOGY SYSTEM

    K Number: K933455 · Decision Jan 31, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    41
    Applicant Total
    13
    Review Days
    201

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    Basic Information

    Device Name
    COMPUTED ORAL RADIOLOGY SYSTEM
    K Number
    K933455
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1810
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Schick Technologies, Inc.
    Date Received
    July 14, 1993
    Decision Date
    January 31, 1994
    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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