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510(k) Data Aggregation

    K Number
    K222792
    Device Name
    SNUCONE Tissue Level Implant System
    Manufacturer
    Snucone Co., Ltd.
    Date Cleared
    2023-06-08

    (265 days)

    Product Code
    DZE, NHA
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Snucone Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SNUCONE Tissue Level Implant System is inticated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations and terminal or internediate Abutment support for fixed bridge work. Snucone implant system is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.
    Device Description
    SNUCONE Implant System Fixture, also known as an endosseous implant, is surgical component that interfaces with the bone of the jaw or skull to support a dental prosthesis such as a crown, bridge, denture. Snucone's abutment and prosthetic components and tools are compatible with the Snucone's fixture only. The system includes Fixtures and Cover Screw, and Abutment and Component (Solid Abutment, InOcta Closing Screw, InOcta Healing Abutment, InOcta Abutment, InOcta Angled Abutment, InOcta Temporary Abutment, Platform Switching Abutment, and Abutment Screw).
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    K Number
    K210354
    Device Name
    SNUCONE Bone Level Implant System
    Manufacturer
    SNUCONE Co., LTD.
    Date Cleared
    2022-07-13

    (520 days)

    Product Code
    DZE, NHA
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    SNUCONE Co., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SNUCONE Bone Level Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations and terminal or intermediate Abutment support for fixed bridge work. SNUCONE Bone Level Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.
    Device Description
    SNUCONE Implant System Fixture, also known as an endosseous implant, is surgical component that interfaces with the bone of the jaw to support a dental prosthesis such as a crown, bridge, denture. Snucone's abutment and prosthetic components and tools are compatible with the Snucone's fixture only.
    Ask a Question

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