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

    ENDODONTIC ELECTRONIC SPREADER HEATER

    K Number: K853183 · Decision Oct 16, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    78

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    Basic Information

    Device Name
    ENDODONTIC ELECTRONIC SPREADER HEATER
    K Number
    K853183
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Sturgeon Engineering Co.
    Date Received
    July 30, 1985
    Decision Date
    October 16, 1985
    Product Code
    EKK
    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
    EKK Spreader, Pulp Canal Filling Material, Endodontic

    Other Clearances by Sturgeon Engineering Co.

    K Number Device Name
    K852942 WORLD PORTABLE CAUTERY