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

    ELEMENTS DIAGNOSTIC UNIT

    K Number: K021298 · Decision Jun 19, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    21
    Applicant Total
    3
    Review Days
    56

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    Basic Information

    Device Name
    ELEMENTS DIAGNOSTIC UNIT
    K Number
    K021298
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1720
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sybron Endo/Analytic
    Date Received
    April 24, 2002
    Decision Date
    June 19, 2002
    Product Code
    EAT
    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
    EAT Tester, Pulp

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