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510(k) Data Aggregation

    K Number
    K243190
    Device Name
    USTOMED Bone Fixation/Bone Augmentation Systems - PIN
    Manufacturer
    Ustomed Instrumente Ulrich Storz GmbH & Co. KG
    Date Cleared
    2025-06-27

    (270 days)

    Product Code
    DZL
    Regulation Number
    872.4880
    Why did this record match?
    Product Code :

    DZL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    USTOMED Bone Fixation/Bone Augmentation Systems – PIN is intended for fastening membranes during bone regenerative treatment.
    Device Description
    USTOMED Bone Fixation/Bone Augmentation Systems – PIN consists of a titanium pin. The Pin can be used to fasten third-party non-absorbable PTFE and titanium-reinforced membranes up to a thickness of 1.0mm cleared by FDA for stabilization and support of bone grafts in dento-alveolar bony defect sites (product code JEY). After fulfilling its supportive function, which is typically achieved within three to nine months, the Pin must be removed, as it is not intended to remain in the body permanently. The Pin are intended for single use and provided non-sterile for cleaning and sterilization by the user before use.
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    K Number
    K233419
    Device Name
    GBR System
    Manufacturer
    Proimtech Saglik Urunleri Anonim Sirketi
    Date Cleared
    2025-01-03

    (451 days)

    Product Code
    DZL
    Regulation Number
    872.4880
    Why did this record match?
    Product Code :

    DZL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Guided Bone Regeneration (GBR) System is used to stabilize and fix bone filling materials and/or barrier membranes used for bone regeneration in the oral cavity.
    Device Description
    The Guided Bone Regeneration (GBR) System is used to stabilize and fix bone filling materials and/or barrier membranes used for bone regeneration in the oral cavity. MATERIALS: Only materials approved for medical purposes are used in the manufacture of products: Pure Titanium Grade 4 according to standard ISO 5832-2 and ASTM F67-13.
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    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?
    Product Code :

    DZL

    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
    K233721
    Device Name
    KLS Martin Drill-Free MMF Screw
    Manufacturer
    KLS-Martin L.P.
    Date Cleared
    2024-09-17

    (301 days)

    Product Code
    DZL
    Regulation Number
    872.4880
    Why did this record match?
    Product Code :

    DZL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KLS Martin Drill-Free MMF Screw is indicated for temporary stabilization of mandibular and maxillary fractures to maintain proper occlusion during surgery in adults and adolescents (age 12 and older) in whom permanent teeth have erupted.
    Device Description
    The KLS Martin Drill-Free MMF Screw are bone-borne, self-drilling screws for maxillomandibular fixation (MMF). The screws are intended to provide stabilization of mandibular and maxillary fractures as well as maintain proper occlusion during intraoneralive bone fixation. These screws may be applied prior to or after exposure of the Drill Free MMF Screw is manufactured from stainless steel (ASTM F138) with a head designed with a hole to allow passing and securing ligature wire during the procedure and is available in threaded lengths of 2.0 x 8.0 mm - 2.0 x 12.0mm. Implants are available both sterile and non-sterile.
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    K Number
    K231599
    Device Name
    Stryker MP, Mandible, HMMF and MMF AXS Screws
    Manufacturer
    Stryker Leibinger GmbH & Co. KG
    Date Cleared
    2023-08-24

    (84 days)

    Product Code
    DZL
    Regulation Number
    872.4880
    Why did this record match?
    Product Code :

    DZL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K222367
    Device Name
    SAVE GBR
    Manufacturer
    Dentis Co., Ltd.
    Date Cleared
    2023-03-23

    (230 days)

    Product Code
    DZL
    Regulation Number
    872.4880
    Why did this record match?
    Product Code :

    DZL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use in stabilizing and fixating bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only.
    Device Description
    SAVE GBR is manufactured by Ti-6Al-4V ELI. The SAVE GBR is composed of GBR Screw and Bone Tack and these screws and tacks are used to fix barrier membranes in bone regeneration procedures. The diameter of the GBR screw is 1.4 and length is 3.9, 4.38, 5.9, 6.38, 7.9 and 8.38mm. The diameter of the Bone Tack is 2.5 and length is 2.6 and 4.1mm. These screws and tacks are implanted for a maximum duration of 6 months. The SAVE GBR is provided sterile. The subject device is compatible with the OssBuilder membrane cleared in K172354.
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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?
    Product Code :

    DZL

    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
    K201561
    Device Name
    Membrane Screws and Membrane Tacks
    Manufacturer
    Neoss Limited
    Date Cleared
    2020-10-05

    (117 days)

    Product Code
    DZL
    Regulation Number
    872.4880
    Why did this record match?
    Product Code :

    DZL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Membrane Tacks and Membrane Screws are intended for fastening membranes during bone regenerative treatment. These membrane fastening means are in direct body contact, intended for temporary use only. Membrane fastening means are submerged and clinically implanted more than 30 days with an expected duration of three to nine months or until bone regeneration is complete taking into account which membrane and bone grafting materials are being used.
    Device Description
    Membrane Tacks and Membrane Screws are regenerative membrane fastening devices available in 3mm length. The Membrane Tack is used in conjunction with a Tack Positioning Instrument, while the Membrane Screw is applied with the Neoss Implant Inserter. Regenerative membranes are designed to prevent ingrowth of gingival soft tissue into bony defects, in order to facilitate the bone formation during the repair process of the defect. Membrane Tacks and Screws are made of titanium while related instruments are made in stainless steel. The Membrane fastening devices are single-use only while the instruments are for multiple use.
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    K Number
    K182881
    Device Name
    Bone Screw, Bone Tack
    Manufacturer
    Osstem Implant Co., Ltd.
    Date Cleared
    2019-08-09

    (298 days)

    Product Code
    DZL
    Regulation Number
    872.4880
    Why did this record match?
    Product Code :

    DZL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bone Screw is used to stabilize and fixate bone grafts, bone filling material, and/or barrier membranes used for regeneration of bone in the oral cavity. Bone Tack is indicated for use to stabilize and support bone graft and/or fractured bone segments with or without bone plates or titanium mesh in oral and maxillofacial site defects.
    Device Description
    Bone Screw is using as anchor to fix the bone plate, membrane that cover bone material or block bone for bone regeneration or remodeling. Ø1.4 diameter screw is for fixing membrane or bone plate, and Ø2.0 diameter screw is for fixing block bone. Bone Tack is a stabilizer that can stably fix the membrane in GBR.
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    K Number
    K181854
    Device Name
    OssBuilder System
    Manufacturer
    Osstem Implant Co., Ltd..
    Date Cleared
    2019-05-07

    (300 days)

    Product Code
    DZL, NHA
    Regulation Number
    872.4880
    Why did this record match?
    Product Code :

    DZL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OssBuilder System is used for space maintenance and stabilization of bone grafting material in an alveolar bone defect site.
    Device Description
    OssBuilder System is consisted of metal devices, OssBuilder, Healing Cap, Cover Cap, OB Anchor, and Tenting Screw, and is intended for use to stabilize and support of bone graft in dento-alveolar bony defect sites. Tenting Screw, a product in the OssBuilder System product group, is a temporary dental implant that can be implanted in the bone defect site of the alveolar bone to fix the guided tissue regeneration material. Healing Cap is used by connecting with the Tenting Screw to bind OssBuilder during osseointegration.
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