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510(k) Data Aggregation

    K Number
    K240321
    Device Name
    MP Pin flat without thread (36BMP000020/MP20)
    Manufacturer
    Hager & Meisinger GmbH
    Date Cleared
    2024-10-17

    (258 days)

    Product Code
    DZL
    Regulation Number
    872.4880
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hager & Meisinger GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MP Pins without thread, flat head are indicated for the fixation of apical membrane ends at the local bone in order to avoid micromobility of the membrane. They allow for the fixation of resorbable and non-resorbable membranes.
    Device Description
    Pin with a flat head for the fixation of resorbable and non-resorbable membranes.
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    K Number
    K201210
    Device Name
    The Micro Screw System, Micro Screw System Basic
    Manufacturer
    Hager & Meisinger GmbH
    Date Cleared
    2021-10-08

    (521 days)

    Product Code
    DZL
    Regulation Number
    872.4880
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hager & Meisinger GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Micro Screw System, Micro Screw System Basic are developed and manufactured to be used as non-active bone surgery implants for the treatment of bone fractures, especially for the fixation of transplanted bone blocks during the augmentation process in the oral cavity and maxillomandibular surgical field. Note: Micro Screws are not intended to remain in the body permanently. After they have fulfilled their supportive function such as is the case after healing of a transplant, or healing of a fracture, for example, they need to be removed completely.
    Device Description
    The Micro Screw System, Micro Screw System Basic are used for the safe fixation and stabilisation of cortical bone grafts. These systems contain osteosynthesis screws made of surgical stainless steel with diameters of 1.0 mm and 1.2 mm.
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    K Number
    K173819
    Device Name
    MyPlant II Implant System
    Manufacturer
    Hager & Meisinger GmbH
    Date Cleared
    2018-08-09

    (234 days)

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

    Hager & Meisinger GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MyPlant II implants are surgically placed in the maxilla or mandible to enable prosthetic restorations in edentulous or partially edentulous patients. The implants are to be used exclusively prith MyPlason and and prosthetic components. The abutments serve for prosthetic restorations and can include individual crowns, bridges, partial or full prostheses. Abutments can be used for single tooth restorations or for the restoration of several teeth. The implants are intended for delayed loading with two surgical interventions. In castof oppriate primary stability (35 Ncm), immediate temporary restoration with appropriate occlusal load can also be appriverad.
    Device Description
    The MyPlant II implant system serves as a tooth root substitute and can be used in free jaw sections or edentulous jaws. The MyPlant II implant is made of pure titanium Grade 4 (3.7065). The implant surface is micro-structured. The surface structure is created by blasting with white corundum (> 99 % AlsO3 = aluminum oxide) and etching with acid. Prosthetic connection and thus force transmission is conveyed via an internal cone. A sterile cover screw of 1 mm height is enclosed with each implant to enable an immediate occlusion of the internal thread after successful insertion. The implants are supplied sterile and are intended for single use. MyPlant II Implant System includes various implant variations with different diameters and lengths. Dental abutments are used to support prosthetic reconstruction. Prosthetic applications can include individual crowns, bridges, partial or full prostheses. Abutments can be used for the replacement of one or more teeth. Depending on the indication and the anatomical conditions, the user will use several components for the specific prosthetic purpose. All components are made of a material suitable for the purpose of the application. The abutments are made of pure titanium Grade 4 (3.7065), titanium alloy Grade 5-ELI (Grade 23/3.7165), or PEEK. Except for the PEEK healing caps, the abutment surface is anodized. Connection to the implant is assured via an internal tapered connection as well as a metric thread. In the case of Abutments 0° / 15° and Shoulder Abutments, the abutment screw is not anodized and undergoes laser welding to connect the threaded sleeves with the shaft. The subject abutments are listed in a table with article number, description, and specifications.
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    K Number
    K180360
    Device Name
    OKTAGON Implant System
    Manufacturer
    Hager & Meisinger GmbH
    Date Cleared
    2018-05-10

    (90 days)

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

    Hager & Meisinger GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental implants OKTAGON® are surgically placed in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. The implants are intended to be used with OKTAGON® abutments and prosthetic parts. The implants are intended for delayed loading in a two-stage surgery or for immediate loading when good primary stability is achieved and with appropriate occlusal load.
    Device Description
    The proposed implants represent a line extension of dental implants OKTAGON®, which have been previously cleared in the submissions K170287, K162073 and K143539. The proposed implants have a root-form design and are made of Titanium Grade 4 conforming to ASTM F67-13. The surface is microstructured in the endosteal section by blasting with high-grade corundum and acid-etching. Tissue Level Conical Implants have a conical shape, and the endosteal body of Bone Level Tapered Design Implants is cylindrical in the coronal region and conical in the apical region. The prosthetic connection is achieved with the help of an inner cone with an additional octagonal antirotation device. A sterile cover screw is enclosed with the implant so that an immediate occlusion of the internal thread is possible after successful insertion. OKTAGON® Implant System includes four variations of the prosthetic connection: Tissue Level Implants: Regular Platform (RP) and Wide Platform (WP) Bone Level Implants: Regular Connect (RC) and Narrow Connect (NC). The proposed Tissue Level Conical Implants will increase the range of lengths available for this implant variation. The proposed Bone Level Tapered Design implants will be offered in the same range of lengths as the predicate devices, but with an increased diameter. The proposed healing abutments increase the range of diameters available for Bone Level Narrow Connect implants. They are manufactured from Titanium Grade 4, and are intended to close the implant and shape the surrounding soft tissue during the healing phase. No occlusal loading is intended.
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    K Number
    K170287
    Device Name
    Dental Implants OKTAGON Bone Level Tapered Design
    Manufacturer
    Hager& Meisinger GmbH
    Date Cleared
    2017-05-24

    (114 days)

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

    Hager& Meisinger GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dental Implants OKTAGON® Bone Level Tapered Design are surgically placed in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous patients. The implants are intended to be used with OKTAGON® abutments and prosthetic parts. The implants are intended for delayed loading in a two-stage surgery or for immediate loading when good primary stability is achieved and with appropriate occlusal load.
    Device Description
    The Dental Implants OKTAGON® Bone Level Tapered Design are an addition to the currently distributed Dental Implant System® OKTAGON Bone Level. The implants can be used for immediate or early implantation after loss or extraction of natural teeth. The endosteal implant body of the subject device has a conical shape in the coronal region and is cylindrical in the apical region. The apical cylindrical part of the implant is relevant for the given endosteal diameter of 3.3 to 4.1 mm. The implants are made of commercially pure Titanium Grade 4 conforming to ASTM- F67. The surface is micro-structured in the endosted part and has been blasted with high-grade corundum and afterwards acid-etched. The implant shoulder is polished. The prosthetic connection is achieved with the help of an inner cone with an additional octagonal antirotation device. A sterile cover screw is enclosed with the implant so that an immediate occlusion of the internal thread is possible after successful insertion.
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    K Number
    K162073
    Device Name
    Dental Implants OKTAGON Tissue Level and Bone Level
    Manufacturer
    HAGER & MEISINGER GMBH
    Date Cleared
    2017-02-24

    (212 days)

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

    HAGER & MEISINGER GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The implants are surgically placed in the maxillary and/ or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. The parts are intended to be used with OKTAGON® respectively Bone Level abutments and prosthetic parts. The OKTAGON Implant System is intended for delayed loading, or for immediate loading when good primary stability is achieved and with appropriate occlusal load.
    Device Description
    The Dental Implants OKTAGON® Tissue Level and Bone Level follow a root-form design and are made of commercially pure Titanium Grade 4 conforming to ASTM- F67. The surface is microstructured in the endosteal section and the surface has been blasted with high-grade corundum and afterwards acid-etched. The implant shoulder of Dental Implants OKTAGON® Tissue Level and Bone Level is polished. The prosthetic connection is achieved with the help of an inner cone with an additional octagonal antirotation device. A sterile cover screw is enclosed with the implant so that an immediate occlusion of the internal thread is possible after successful insertion. Subject to this submission are the following implant variations: BL NC Ø3.75 mm, L 8 mm BL NC Ø3.75 mm, L 10 mm BL NC Ø3.75 mm, L 12 mm TL RP Ø3.75 mm, L 8 mm TL RP Ø3.75 mm, L 10 mm TL RP Ø3.75 mm, L 12 mm TL RP Conical Ø4.1 mm, L 10 mm
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    K Number
    K160132
    Device Name
    Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC
    Manufacturer
    HAGER & MEISINGER GMBH
    Date Cleared
    2016-11-21

    (306 days)

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

    HAGER & MEISINGER GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental Implant Abutments Bone Level are intended to provide support for prosthetic reconstructions. Prosthetic applications can include individual crowns, bridges, partial or total prostheses. Abutments can be used in single tooth replacements and multiple tooth restorations. The Abutments are intended to be compatible to OKTAGON® Bone Level implants with diameters 3.3mm, 4.1mm and 4.8mm and with the lengths 8mm, 10mm, 12mm and 14mm. The Dental Implant System OKTAGON® Bone Level is intended for delayed loading, or for immediate loading when good primary stability is achieved and with appropriate occlusal load.
    Device Description
    The Dental Implant System OKTAGON® Bone Level is an integrated system of endosseous dental implants which are designed to support prosthetic devices for partially of fully edentulous patients. The devices covered in this submission are angled abutments and an addition to the currently available Dental Implants and Abutments OKTAGON® Bone Level. The abutments are made of Titanium Grade 4, the alligator abutments and screws are made of Titanium Alloy (TiAl6V4); the connection to the implants is achieved by an internal octagon/nut construction and a metric thread.
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    K Number
    K143539
    Device Name
    Dental Implant OKTAGON Bone Level
    Manufacturer
    Hager & Meisinger GmbH
    Date Cleared
    2015-08-31

    (259 days)

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

    Hager & Meisinger GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The implants are surgically placed in the maxillary and/ or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. The implants are intended to be used with OKTAGON® Bone Level abutments and prosthetic parts. Dental Implant Abutments Bone Level are intended to provide support for prosthetic reconstructions. Prosthetic applications can include individual crowns, bridges, partial or total prostheses. Abutments can be used in single tooth replacements and multiple tooth restorations. The Abutments are intended to be compatible to OKTAGON® Bone Level implants with diameters 3.3mm, 4.1mm and 4.8mm and with the lengths 8mm, 10mm, 12mm and 14mm. The Oktagon Bone Level System is intended for delayed loading, or for immediate loading when good primary stability is achieved and with appropriate occlusal load.
    Device Description
    The Bone Level Implant is an addition to the currently distributed OKTAGON® dental implant system. The root-form designed implant is made of commercially pure Titanium Grade 4 conforming to ASTM Standard Specification F67. The surface is micro-structured in the endosteal section and the implant shoulder is polished. The implant surface has been blasted with high-grade corundum and afterwards acid-etched. The prosthetic connection is achieved with the help of an inner cone with an additional octagonal anti-rotation device. A sterile locking screw is enclosed with the implant so that an immediate occlusion of the internal thread is allowed after successful insertion. The endosseous dental implants are available in a range of endosseous diameters and lengths. The abutments are available in different versions including the corresponding screws. The abutments are made of Titanium Grade 4, Titanium Alloy or POM; the connection to the implants is achieved by an internal octagon/nut construction and a metric thread. The following types of abutments will be available: - . Cover screw - Healing abutment - Straight abutment ● - Alligator abutment
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    K Number
    K132214
    Device Name
    ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIGATOR ABUTMENT, SOLID ABUTMENT, RETENTIVE
    Manufacturer
    HAGER & MEISINGER GMBH
    Date Cleared
    2014-07-07

    (356 days)

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

    HAGER & MEISINGER GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental Implant Abutments are intended to provide support for prosthetic reconstructions. Prosthetic applications can include individual crowns, bridges, partial or total prostheses. Abutments can be used in single tooth replacements and multiple tooth restorations. The Dental Implant Abutments OKTAGON® are intended to be compatible to OKTAGON® implants (Dental Implant OKTAGON®) with diameters 3.3mm, 4.1mm and 4.8mm in the variation Regular Platform, Wide Platform and Tapered Design with the lengths 8mm, 10mm, 12mm and 14mm.
    Device Description
    The OKTAGON® Dental Implant System is an integrated system of endosseous dental implants which are designed to support prosthetic devices for partially of fully edentulous patients. The devices covered in this submission are abutments in different version including the corresponding screws. The abutments are made of Titanium Grade 4, Titanium Alloy or POM; the connection to the implants is achieved by an internal octagon and a metric thread.
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    K Number
    K122807
    Device Name
    DENTAL IMPLANT SYSTEM
    Manufacturer
    HAGER & MEISINGER GMBH
    Date Cleared
    2014-06-13

    (652 days)

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

    HAGER & MEISINGER GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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