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

    S.I.N. Dental Implant System

    K Number: K221453 · Decision Dec 15, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    5
    Review Days
    210

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    Basic Information

    Device Name
    S.I.N. Dental Implant System
    K Number
    K221453
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    S.I.N. – Sistema DE Implante Nacional S.A.
    Date Received
    May 19, 2022
    Decision Date
    December 15, 2022
    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 S.I.N. – Sistema DE Implante Nacional S.A.

    K Number Device Name
    K230069 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