BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇷 Brazil

    Neodent Implant System - Zirconia Implant System

    K Number: K231803 · Decision Dec 13, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    382
    Registration Numbers
    382
    Same Product Code
    708
    Applicant Total
    11
    Review Days
    176

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    Basic Information

    Device Name
    Neodent Implant System - Zirconia Implant System
    K Number
    K231803
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    JJGC Indústria e Comércio de Materiais Dentários S.A.
    Date Received
    June 20, 2023
    Decision Date
    December 13, 2023
    Product Code
    NHA
    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
    NHA Abutment, Implant, Dental, Endosseous

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    Other Clearances by JJGC Indústria e Comércio de Materiais Dentários S.A.

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    K232099 Neodent Implant System - GM Zygomatic Implant System
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