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

    Neodent Implant System - Custom Abutments

    K Number: K250614 · Decision May 27, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    390
    Registration Numbers
    390
    Same Product Code
    672
    Applicant Total
    2
    Review Days
    88

    Basic Information

    Device Name
    Neodent Implant System - Custom Abutments
    K Number
    K250614
    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 Comércia de Materiais Dentários S.A.
    Date Received
    February 28, 2025
    Decision Date
    May 27, 2025
    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 Comércia de Materiais Dentários S.A.

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    K242686 Neodent Implant System