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

    QUANTEC-E ENDO SYSTEM

    K Number: K990739 · Decision May 26, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    88
    Applicant Total
    106
    Review Days
    82

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    Basic Information

    Device Name
    QUANTEC-E ENDO SYSTEM
    K Number
    K990739
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sybron Dental Specialties, Inc.
    Date Received
    March 5, 1999
    Decision Date
    May 26, 1999
    Product Code
    EKX
    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
    EKX Handpiece, Direct Drive, Ac-Powered

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