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510(k) Data Aggregation

    K Number
    K231426
    Device Name
    8plant Implant System
    Date Cleared
    2024-05-24

    (373 days)

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

    Hoowon EDI Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    8plant 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 final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Implant bodies with a diameter of 5mm or more are intended to be used in the molar region.
    Device Description
    8plant Implant System consists of SF Fixtures, Cover Screw, Abutment, and Abutment Screw. 1) 8plant Implant System (SF Fixtures and Cover Screw) This titanium dental implant features a SLA (Sandblasted with Large-grit and Acid-etched) surface with the alveolar bone and is designed to support single or multiple-unit restorations in partially or fully edentulous patients. It is secured to the upper structure using an internal hex fastening system. 2) 8plant Abutment System (Abutment and Abutment Screw) 8plant Abutment System is compatible with the SF Fixtures. 8plant Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. The 8plant Abutment System consists of the following; Healing Abutment, Rigid Abutment, Locator Abutment, Transfer Abutment, Angled Abutment, Temporary Abutment, Abutment Screw.
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