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510(k) Data Aggregation

    K Number
    K190919
    Device Name
    ST Internal Implant System
    Manufacturer
    T-Plus Implant Tech. Co., Ltd.
    Date Cleared
    2020-02-27

    (324 days)

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

    T-Plus Implant Tech. Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ST Internal Implant System is intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. The ST Internal Implant System is intended for use for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
    Device Description
    The ST Internal Implant System are made with Grade 4 titanium and surface treatment is done with SLA (Sand-blasted, Large grit, Acid-etched). The systems consist of one-stage and two-stage root form dental implants, associated with abutment systems, which provide the dentist with screw and cement retained restoration options. The devices covered by this system are ST internal implant, screw and abutment. The implants in this system are provided in lengths from 7.0-15.0 and in diameters from 3.7-5.1. The 3.7 diameter implant is not provided in the 7.0 length. The ST implants have two types, one is mini and the other is regular. The mini type diameters of ST implants are 3.7 mm and the lengths are 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm, and 15.0 mm. The regular type diameters of ST implants are 4.2 mm, 4.6 mm, and 5.1 mm, and the lengths are 7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm, and 15.0 mm. EZ Post abutments, solid abutments, Cylinder abutments, angled abutments, mount screws, cover screws, abutment screws and fixture mounts are included in the system.
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    K Number
    K152787
    Device Name
    ST Internal Fixture System
    Manufacturer
    T-PLUS IMPLANT TECH. CO., LTD.
    Date Cleared
    2016-07-22

    (301 days)

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

    T-PLUS IMPLANT TECH. CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ST Internal Fixture System is intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. The ST Internal Fixture System is intended for use for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
    Device Description
    The ST Internal Fixtures are made with Grade 4 titanium. The systems consist of one-stage and two-stage root form dental implants, associated with abutment systems, which provide the dentist with screw and cement retained restoration options. The devices covered by this submission are ST internal fixture, screw and abutment. The diameters of ST internal fixtures are 3.5 mm, 4.0 mm, 4.5 mm, and 5.0 mm, and the lengths are 7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm, and 15.0 mm.
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    K Number
    K152786
    Device Name
    A Plus Internal Fixture System
    Manufacturer
    T-PLUS IMPLANT TECH. CO., LTD.
    Date Cleared
    2016-06-07

    (256 days)

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

    T-PLUS IMPLANT TECH. CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The A Plus Internal Fixture System is intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. It is intended for delayed loading.
    Device Description
    The A Plus internal fixtures are made with Grade 4 titanium. The systems consist of one-stage and two-stage root form dental implants, associated with abutment systems, which provide the dentist with screw and cement retained restoration options. The devices covered by this submission are A Plus internal fixture, screw, abutment and some accessories. The diameters of A Plus internal fixtures are 3.4 mm, 3.8 mm, 4.3 mm, 4.8 mm, and 5.3 mm, and the lengths are 8 mm, 10 mm, 12 mm, and 14 mm.
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    K Number
    K132992
    Device Name
    TI STAR IMPLANT SYSTEM
    Manufacturer
    T-PLUS IMPLANT TECH. CO., LTD.
    Date Cleared
    2013-12-18

    (85 days)

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

    T-PLUS IMPLANT TECH. CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ti Star Implant System is intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. The Ti Star Implant System is intended for use for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
    Device Description
    The Ti Star Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients. Ti Star Implant System consist of one-stage and two-stage, root form dental implants, associated with abutment systems, which provide the dentist with screw and cement retained restoration options. The devices covered by this submission are Ti Star Implant Fixtures, abutments, cover screw, closing screw and healing screw. The diameters of implant fixture are 3.5mm, 4.1mm and 4.8mm, the lengths are 7.0mm, 8.5mm, 10.0mm, 11.5mm, 13.0mm and 15.0mm.
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