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

    SHAPING HEDSTROM N.T.

    K Number: K953604 · Decision Sep 28, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    30
    Applicant Total
    106
    Review Days
    57

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    Basic Information

    Device Name
    SHAPING HEDSTROM N.T.
    K Number
    K953604
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sybron Dental Specialties, Inc.
    Date Received
    August 2, 1995
    Decision Date
    September 28, 1995
    Product Code
    EKS
    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
    EKS File, Pulp Canal, Endodontic

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