BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    SIC invent Dental Implant Systems

    K Number: K173207 · Decision Apr 5, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    5
    Review Days
    185

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    Basic Information

    Device Name
    SIC invent Dental Implant Systems
    K Number
    K173207
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sic Invent AG
    Date Received
    October 2, 2017
    Decision Date
    April 5, 2018
    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 Sic Invent AG

    K Number Device Name
    K252904 SIC Abutments including CAD/CAM Solutions
    K210489 SICtapered & SICvantage tapered
    K061500 SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS
    K040757 SIC PRO