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

    PURE TITANIUM SCREW-TYPE FOR DENTAL IMPLANT

    K Number: K860653 · Decision Apr 17, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    2
    Review Days
    55

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    Basic Information

    Device Name
    PURE TITANIUM SCREW-TYPE FOR DENTAL IMPLANT
    K Number
    K860653
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Otc/America
    Date Received
    February 21, 1986
    Decision Date
    April 17, 1986
    Product Code
    DZE
    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
    DZE Implant, Endosseous, Root-Form

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    Other Clearances by Otc/America

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