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

    TOUCH 'N HEAT MODEL 5002, MODIFICATION

    K Number: K915243 · Decision Jan 21, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    22
    Applicant Total
    9
    Review Days
    82

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    Basic Information

    Device Name
    TOUCH 'N HEAT MODEL 5002, MODIFICATION
    K Number
    K915243
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3850
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Analytic Technology
    Date Received
    October 31, 1991
    Decision Date
    January 21, 1992
    Product Code
    EKM
    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
    EKM Gutta-Percha

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