Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K222707
    Device Name
    IH Implant System
    Manufacturer
    Sewon Medix Inc.
    Date Cleared
    2023-07-07

    (303 days)

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

    Sewon Medix Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IH Implant System is device made of titanium alloy indicated for in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained restorations and terminal or interminal abutment support for fixed bridgework. IH Implant System is for stage surgical procedures. It is intended for delayed loading.
    Device Description
    IH Implant System is device made of titanium alloy indicated for in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained restorations and terminal or interminal abutment support for fixed bridgework. IH Implant System is for stage surgical procedures. It is intended for delayed loading. The system includes IH2 SLA Fixtures, IH Healing Abutments, IH Cement Abutments, and IH Multi-unit Abutments. The fixtures are endosseous threaded implants with a surface treatment of sand blasting and acid etching. The abutments are premanufactured and connect directly to the implant. The materials used are Pure Titanium Grade 4 (ASTMF67-06) and Titanium Alloy (ASTM F 136).
    Ask a Question
    K Number
    K153521
    Device Name
    IH Implant System
    Manufacturer
    Sewon Medix Inc.
    Date Cleared
    2016-10-14

    (311 days)

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

    Sewon Medix Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IH Implant System is device made of titanium and titanium alloy indicated for in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including ; cemented retained or screw retained restorations and terminal abutment support for fixed bridgework. IH Implant System is for single and two stage surgical procedures. It is intended for delayed loading.
    Device Description
    IH2 SLA Fixture is dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is SLA (Sandblasted, Large grit and Acid etched) treated. IH2 SLA Fixture has a various diameters 3.7 to 5.1 mm (3.7, 4.2, 4.6 and 5.1mm) and lengths 8.5 to 15mm (8.5, 10, 11.5, 13 and 15mm). IH Prosthetic System is device made of titanium alloy, CCM alloy and POM intended for use as an aid in prosthetic restoration. It consists of Abutments (Healing Abutment, Solid Abutment, Cement Abutment, Angled Abutment, Temporary Abutment, Multi-unit Abutment and FreeMilling Abutment), Solid Protect Cap, Abutment Screws, Healing Cap, Cylinders (CCM Cylinder, Temporary Cylinder, Plastic Cylinder) and Cylinder Screws. Its surfaces are partially TiN coated or uncoated. IH Prosthetic System is supplied non-sterile and should be sterilized before use. It has a various diameters, gingival heights, heights and angles.
    Ask a Question

    Page 1 of 1