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

    Zeramex P6 Dental Implant System

    K Number: K152385 · Decision Jul 27, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    4
    Review Days
    338

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    Basic Information

    Device Name
    Zeramex P6 Dental Implant System
    K Number
    K152385
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dentalpoint AG
    Date Received
    August 24, 2015
    Decision Date
    July 27, 2016
    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 Dentalpoint AG

    K Number Device Name
    K180184 Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System
    K163043 Zeramex P6 Dental Implant System
    K133255 ZERAMEX T AND ZERAMEX PLUS DENTAL IMPLANT SYSTEMS