BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    REVISED T-SCAN SYSTEM

    K Number: K870032 · Decision Feb 2, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    9
    Applicant Total
    1
    Review Days
    28

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    Basic Information

    Device Name
    REVISED T-SCAN SYSTEM
    K Number
    K870032
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6140
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Sentek, Inc.
    Date Received
    January 5, 1987
    Decision Date
    February 2, 1987
    Product Code
    EFH
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EFH Paper, Articulation

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