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510(k) Data Aggregation

    K Number
    K202039
    Device Name
    Honorst Implant System
    Manufacturer
    Medimecca Co., Ltd.
    Date Cleared
    2020-09-25

    (64 days)

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

    Medimecca Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Honorst Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Honorst Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading.
    Device Description
    Honorst Implant System are devices made of titanium intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices such as artificial teeth, and to restore the patients chewing function. Honorst Implant System consists of fixtures, abutments, and screws. Its material, structure and intended use are substantial equivalent to the predicate devices in the market. Honorst Implant System offers two different implants in SLA treatment and also offers two different onebody implants in SLA treatment. The Milling Abutment is only to be hand milled and not undergo CAD/CAM fabrication.
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    K Number
    K160536
    Device Name
    Chaorum Implant System
    Manufacturer
    MEDIMECCA CO., LTD.
    Date Cleared
    2017-01-05

    (314 days)

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

    MEDIMECCA CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Chaorum Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Chaorum Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading.
    Device Description
    Chaorum Implant System are devices made of titanium intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices such as artificial teeth, and to restore the patients chewing function. Chaorum Implant System consists of fixtures, abutments, and screws. Its material, structure and intended use are substantially equivalent to the predicate devices. It offers three different implants in RBM treatment and SLA treatment.
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    K Number
    K131682
    Device Name
    UD IMPLANT SYSTEM
    Manufacturer
    MEDIMECCA CO., LTD.
    Date Cleared
    2013-12-05

    (178 days)

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

    MEDIMECCA CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UD Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. UD Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading.
    Device Description
    UD Implant System is a dental implant system made of titanium (Fixture: ASTM F136 / Prosthetic Abutment: ASTM F136, ASTM F67 Gr 4) intend to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. This device may be used to replace one or more missing teeth. Its material, structure and intended use are substantial equivalence with the predicate device.
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    K Number
    K130221
    Device Name
    HERO II DENTAL IMPLANT SYSTEM, UI DENTAL IMPLANT SYSTEM
    Manufacturer
    MEDIMECCA CO., LTD.
    Date Cleared
    2013-03-21

    (51 days)

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

    MEDIMECCA CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hero II Dental Implant System and the UI Dental Implant System are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The Hero II Dental Implant System and the UI Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.
    Device Description
    The Hero II Dental Implant System and the UI Dental Implant System are dental implant systems made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of these systems have been treated with R.B.M (Resorbable Blast Media) for fixtures and TiN coating for abutments.
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