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

    THERMAPREP

    K Number: K910224 · Decision Mar 29, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    22
    Applicant Total
    8
    Review Days
    70

    Basic Information

    Device Name
    THERMAPREP
    K Number
    K910224
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3850
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    TULSA DENTAL PRODUCTS, LTD.
    Date Received
    January 18, 1991
    Decision Date
    March 29, 1991
    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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