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

    SPLINE DENTAL IMPLANT SYSTEM

    K Number: K010073 · Decision Jan 19, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    9
    Review Days
    10

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    Basic Information

    Device Name
    SPLINE DENTAL IMPLANT SYSTEM
    K Number
    K010073
    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
    January 9, 2001
    Decision Date
    January 19, 2001
    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 Sulzer Calcitek, Inc.

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