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510(k) Data Aggregation

    K Number
    K202046
    Device Name
    LOTA SLA Dental Implant System and LOTA HA Dental Implant System
    Manufacturer
    KJ Meditech Co., Ltd.
    Date Cleared
    2022-03-01

    (586 days)

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

    KJ Meditech Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LOTA SLA Dental Implant System and LOTA HA 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 LOTA SLA Dental Implant System and LOTA HA Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.
    Device Description
    The LOTA SLA Dental Implant system and LOTA HA Dental Implant System are dental implant systems made of Titanium 6AL 4V ELI alloy, which confirms to ASTM F136, 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. All diameters are available with all lengths. The implants are used with the following abutments. The Shouldered Abutments and the Shouldered Hex Abutments have internal connection structure, and they adopt locking taper connection. They restore fixed crown and bridge restorations. The Shouldered Removal Abutment uses screw and locking taper connection to be connected with the fixture. It has the same intended use as the other abutments. All the abutments are not intended for angulation.
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    K Number
    K173116
    Device Name
    KJ ZIRCONIA Implant System
    Manufacturer
    KJ Meditech Co., Ltd
    Date Cleared
    2018-06-28

    (272 days)

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

    KJ Meditech Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KJ ZIRCONIA Implant System is intended to use in the treatment of missing teeth to support prosthetic device, such as artificial teeth, in order to restore mastication in partially edentulous patients. It is for delayed loading.
    Device Description
    KJ ZIRCONIA Implant System is a dental implant system made of ZIRCONIA intended to be surgically placed in the bone of the upper or lower jaw arches. It is one piece type implant which the implant and the abutment are manufactured as one piece. It offers two types: BL type and BS type, and the difference is only in the length of the abutment part.
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    K Number
    K161923
    Device Name
    J2A SLA Dental Implant System
    Manufacturer
    KJ Meditech Co., Ltd.
    Date Cleared
    2017-11-09

    (484 days)

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

    KJ Meditech Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The J2A SLA Dental 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, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The J2A SLA Dental Implant System is for single and two stage surgical procedures. The system is intended for delayed loading.
    Device Description
    The J2A SLA Dental Implant System is internal hexagon type 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 system is 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 the system has been treated with SLA (sandblasted, Large- grit, Acid-etched).
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    K Number
    K151970
    Device Name
    KJ Mini Implant System
    Manufacturer
    KJ MEDITECH CO., LTD.
    Date Cleared
    2016-10-21

    (463 days)

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

    KJ MEDITECH CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KJ Mini Implant System is intended to use in the treatment of missing teeth to support prosthetic device, such as artificial teeth, in order to restore mastication in partially edentulous patients. 2.0mm, 2.5mm, and 3.0mm diameter implants are intended to be used in central or lateral mandibular incisors. The KJ Mini Implant System is intended for single use only. It is for delayed loading.
    Device Description
    KJ Mini Implant System is a dental implant system made of Titanium 6AL 4V ELI Gt.23 alloy intended to be surgically placed in the bone of the upper or lower jaw arches. The system is 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 the fixture part has been treated with R.B.M. The KJ Mini Implant System offers the following implants with various sizes.
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    K Number
    K150060
    Device Name
    J2A Dental Implant System, J2C Dental Implant System
    Manufacturer
    KJ MEDITECH CO., LTD
    Date Cleared
    2015-04-02

    (79 days)

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

    KJ MEDITECH CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The I2A Dental Implant System and I2C Dental Implant System are 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 bridgework. The 12A Dental Implant System and J2C Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.
    Device Description
    The J2A Dental Implant System and J2C Dental Implant System are internal hexagon type 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).
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    K Number
    K140051
    Device Name
    KJ EXTERNAL IMPLANT SYSTEM
    Manufacturer
    KJ MEDITECH CO., LTD.
    Date Cleared
    2014-10-30

    (294 days)

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

    KJ MEDITECH CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KJ External 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 bridgework. KJ External Implant System is for stage surgical procedures. It is intended for delayed loading.
    Device Description
    The KJ External Implant System is a dental implant system 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 system is 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 the implants has been treated with R.B.M (Resorbable Blast Media).
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    K Number
    K140052
    Device Name
    J2I IMPLANT SYSTEM
    Manufacturer
    KJ MEDITECH CO., LTD.
    Date Cleared
    2014-10-30

    (294 days)

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

    KJ MEDITECH CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    J2I 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 interminal or intermediate abuments upport for fixed bridgework. J21 Implant System is for single and two stage surgical procedures. It in intended for delating.
    Device Description
    The J2I Implant System is a dental implant system 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 implant may be used to replace one or more missing teeth. The system is 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 the system has been treated with R.B.M (Resorbable Blast Media).
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    K Number
    K121098
    Device Name
    HERO I DENTAL IMPLANT SYSTEM
    Manufacturer
    KJ MEDITECH CO., LTD
    Date Cleared
    2013-01-17

    (281 days)

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

    KJ MEDITECH CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hero I Dental 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, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The Hero I Dental Implant System is for single and two stage surgical procedures. The system is intended for delayed loading.
    Device Description
    The Hero I Dental Implant System is 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 implant may be used to replace one or more missing teeth. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition an performance characteristics. The surface of the system has been treated with R.B.M (Resorbable Blast Media).
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    K Number
    K121047
    Device Name
    HERO II DENTAL IMPLANT SYSTEM, IS DENTAL IMPLANT SYSTEM
    Manufacturer
    KJ MEDITECH CO., LTD
    Date Cleared
    2012-10-04

    (181 days)

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

    KJ MEDITECH CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hero II Dental Implant System and the IS 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 IS 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 IS 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).
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    K Number
    K112787
    Device Name
    KERATOR
    Manufacturer
    KJ MEDITECH CO., LTD
    Date Cleared
    2012-08-08

    (317 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    KJ MEDITECH CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kerator is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla.
    Device Description
    The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The Kerator is made from Titanium grade Ti-6AI-4V ELI (meets ASTM Standard F-136) and compatible with several fixtures made by other manufactures.
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