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

    TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG

    K Number: K001786 · Decision Jun 21, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    9
    Review Days
    8

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    Basic Information

    Device Name
    TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG
    K Number
    K001786
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sulzer Calcitek, Inc.
    Date Received
    June 13, 2000
    Decision Date
    June 21, 2000
    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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