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

    S.I.N. Dental Implant System

    K Number: K230069 · Decision Apr 6, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    382
    Registration Numbers
    382
    Same Product Code
    708
    Applicant Total
    5
    Review Days
    86

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    Basic Information

    Device Name
    S.I.N. Dental Implant System
    K Number
    K230069
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    S.I.N. – Sistema DE Implante Nacional S.A.
    Date Received
    January 10, 2023
    Decision Date
    April 6, 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 S.I.N. – Sistema DE Implante Nacional S.A.

    K Number Device Name
    K221453 S.I.N. Dental Implant System
    K222514 S.I.N. Instrument Kits
    K170392 S.I.N. Implant System
    K170398 S.I.N. Dental Implant System