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510(k) Data Aggregation

    K Number
    K221851
    Device Name
    Lumina-PTFE Titanium
    Manufacturer
    Criteria Industria e Comercio de Produtos Medicinais
    Date Cleared
    2023-12-08

    (529 days)

    Product Code
    NPK
    Regulation Number
    872.3930
    Why did this record match?
    Product Code :

    NPK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lumina-PTFE Titanium is a temporarily implantable material (non-resorbable) indicated for use as a space-making barrier in the treatment of alveolar and periodontal bony defect sites.
    Device Description
    Lumina-PTFE Titanium is a synthetic, biocompatible, single-use, sterile polymeric barrier composed of a 100% polytetrafluoroethylene (PTFE) reinforced by a titanium structure. The titanium frame is embedded between two layers of PTFE. This medical device is placed between bone grafts and the periosteum in dental bone grafting procedures to stabilize and support the bone graft. The PTFE membrane helps create the space needed for bone-derived cells to repopulate and repair the defect. The PTFE membranes are designed to maintain space and conform to tissue contours. Lumina-PTFE Titanium is provided in thicknesses of 0,25mm and different sizes.
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    K Number
    K222549
    Device Name
    OpenTex
    Manufacturer
    Purgo Biologics Inc.
    Date Cleared
    2023-05-11

    (261 days)

    Product Code
    NPK
    Regulation Number
    872.3930
    Why did this record match?
    Product Code :

    NPK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OpenTex is a temporarily implantable material (non-resorbable) for as a space-making barrier in the treatment of periodontal defects.
    Device Description
    OpenTex is a non-resorbable PTFE membrane composed of proprietary 100% polytetrafluoroethylene (PTFE) sheet with inert biological features and predictable barrier effect. OpenTex is designed to function as a physical barrier to avoid gingival cell invasion, thus providing a favorable environment for neovascularization and bone derived cells to repopulate and repair the defect. Since space-making is critical to this procedure, the membrane is sufficiently stiff to prevent spontaneous collapse but supple enough to conform easily to tissue contours. OpenTex is supplied sterile and intended for single use only. It is available in various sizes.
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    K Number
    K211554
    Device Name
    InnoGenic Non-resorbable Membrane
    Manufacturer
    Cowellmedi Co., Ltd.
    Date Cleared
    2023-02-24

    (646 days)

    Product Code
    NPK
    Regulation Number
    872.3930
    Why did this record match?
    Product Code :

    NPK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InnoGenic™ Non-resorbable membrane is a temporarily implantable material (non-resorbable) indicated for stabilization and support of bone grafts in alveolar bony defect sites.
    Device Description
    Not Found
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    K Number
    K210797
    Device Name
    Bio-MEM Ti Reinforced Membrane
    Manufacturer
    B&Medi Co., Ltd.
    Date Cleared
    2022-08-18

    (520 days)

    Product Code
    NPK
    Regulation Number
    872.3930
    Why did this record match?
    Product Code :

    NPK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bio-MEM Ti Reinforced membranes are an implantable temporary non-resorbable device (membrane) for use as a spacer creation barrier in the treatment of local defects in the oral cavity in conjunction with tissue regeneration or augmentation. Bio-MEM Ti Reinforced membranes are intended to be submerged and clinically implanted more than 30 days and no longer than 6 months.
    Device Description
    Bio-MEM Ti Reinforced membranes are non-resorbable membranes available as Tireinforced configured of a highly shapeable Ti (Reinforced only) enveloped by an embossed polytetrafluoroethylene (PTFE) membrane. Extensive documentation demonstrates tissue compatibility of PTFE. Bio-MEM Ti Reinforced membranes are designed to avoid ingrowth of gingival soft tissue into bony defects, in order to facilitate the neovascularization and bone formation during the repair process of the defect. Bio-MEM Ti Reinforced membranes are provided STERILE and in different anatomical shapes and sizes. The titanium reinforcement is intended for space creating and shapemaintaining which minimize movements and subsequent exposure during the regenerative healing.
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    K Number
    K201187
    Device Name
    Cytoplast Titanium-Reinforced PTFE Membranes
    Manufacturer
    Osteogenics Biomedical, Inc.
    Date Cleared
    2021-01-23

    (267 days)

    Product Code
    NPK
    Regulation Number
    872.3930
    Why did this record match?
    Product Code :

    NPK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cytoplast™ Titanium-Reinforced PTFE Membranes are a temporarily implantable material (non- resorbable) indicated for use as a space-making barrier in the treatment of alveolar and periodontal bony defect sites.
    Device Description
    Cytoplast™ Titanium-Reinforced PTFE Membranes are placed between bone grafts and the periosteum in dental bone grafting procedures to stabilize and support the bone graft. The PTFE membrane helps create the space needed for bone-derived cells to repopulate and repair the defect. Cytoplast™ Titanium-Reinforced PTFE Membranes are composed of proprietary 100% polytetrafluoroethylene sheets reinforced with a titanium frame. The titanium frame is embedded between two layers of PTFE. PTFE is biologically nearly inert and a tissue-compatible material. The PTFE membranes are designed to maintain space and conform to tissue contours. Cytoplast™ Titanium-Reinforced PTFE Membranes are provided in two different thicknesses (approximately 150 µm & 250 µm) and are pre-shaped in a variety of shapes and sizes.
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    K Number
    K171774
    Device Name
    RPM Reinforced PTFE Mesh
    Manufacturer
    Osteogenics Biomedical, Inc.
    Date Cleared
    2017-10-19

    (127 days)

    Product Code
    NPK
    Regulation Number
    872.3930
    Why did this record match?
    Product Code :

    NPK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indication and support of bone grafts in alveolar bony defect sites.
    Device Description
    RPM™ Reinforced PTFE Mesh is placed between bone grafts and the periosteum in dental bone grafting procedures to stabilize and support the bone graft. The PTFE mesh helps create the space needed for bone-derived cells to repopulate and repair the defect. RPM™ Reinforced PTFE Mesh is composed of proprietary 100% polytetrafluoroethylene sheets reinforced with a titanium frame. The titanium frame is embedded between two layers of PTFE. PTFE is a biologically inert and tissue-compatible material. RPM™ Reinforced PTFE Mesh is manufactured with circular 0.66 mm diameter macropores to allow direct contact between the bone graft and the periosteum. Direct contact between the periosteum and bone graft allows naturally occurring revascularization and infiltration of cells. The PTFE mesh is designed to maintain space and conform to tissue contours. RPM™ Reinforced PTFE Mesh is provided pre-shaped in a variety of shapes and sizes.
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    K Number
    K160493
    Device Name
    Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm
    Manufacturer
    Salvin Dental Specialties
    Date Cleared
    2016-09-08

    (199 days)

    Product Code
    NPK
    Regulation Number
    872.3930
    Why did this record match?
    Product Code :

    NPK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Salvin CytoSurg™ Non-Resorbable PTFE Membrane is a temporarily implantable material (nonresorbable) for use as a space-making barrier in the treatment of periodontal defects.
    Device Description
    The Salvin CytoSurg™ Non-Resorbable PTFE Membrane is composed of microporous PTFE material. It has a nominal thickness of 250 microns and is supplied in two sizes (25mm x 30mm and 12mm x 24mm). The membranes are single use and are supplied in sterile sealed pouches.
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    K Number
    K151344
    Device Name
    Cytoflex Tefguard Ti-Enforced Membrane
    Manufacturer
    Unicare Biomedical, Inc.
    Date Cleared
    2015-11-19

    (184 days)

    Product Code
    NPK
    Regulation Number
    872.3930
    Why did this record match?
    Product Code :

    NPK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cytoflex® Tef-Guard® Ti-Enforced membrane is a temporarily, non-resorbable, implantable material for use as a space-making barrier in the treatment of periodontal defects and augmentation of alveolar ridge in accordance with guided tissue regeneration principle.
    Device Description
    Cytoflex® Tef-Guard® Ti-Enforced membranes are a multi-layer, non-resorbable membrane intended to be surgically placed under the muco-periosteum to aid in tissue regeneration in accordance with the guided tissue regeneration principle. It is a passive, non-load bearing material with a titanium frame enclosed within two exterior layers of ePTFE material. The titanium reinforcement is intended for space and shape maintenance to contain bone grafting material and to minimize graft migration during wound healing. The membranes are designed to reduce the migration and establishment of gingival tissue derived cells into bony defects thus providing a more favorable environment for neovascularization and bone derived cells to repopulate and repair the defect. The membranes are intended to be submerged and implanted for more than 30 days and up to 6 months. The membrane is supplied sterile and available in a variety of shapes and sizes for single use only.
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    K Number
    K143327
    Device Name
    Neoss Ti Reinforced Membrane
    Manufacturer
    Neoss Ltd
    Date Cleared
    2015-04-13

    (144 days)

    Product Code
    NPK
    Regulation Number
    872.3930
    Why did this record match?
    Product Code :

    NPK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An implantable temporary non-resorbable device (membrane) for use as a spacer creation barrier in the treatment of local defects in the oral cavity in conjunction with tissue regeneration or augmentation. Neoss membranes are intended to be submerged and clinically implanted more than 30 days with an expected duration of implantation up of 6 months.
    Device Description
    The Neoss Ti Reinforced Membrane a multi-layer non-resorbable dental membrane intended to be surgically placed beneath the muco-periosteum to aid in regenerative healing in 1) bone or 2) bone/periodontal ligament defects of the oral cavity. The Neoss Ti Reinforced Membrane is composed of two layers of PTFE membrane material enclosing a Titanium(Ti) mesh. The Neoss Ti Reinforced Membrane is a passive, non-load bearing material. The small pores of the PTFE membrane material, allows passage of fluid and vapor; as well as a controlled cellular ingrowth for stability and a barrier for soft tissue penetration. The Ti mesh is unalloyed surgical grade Titanium ISO 5832-2 Grade 2. The titanium mesh reinforcement is intended for space creating and shape-maintaining which minimizes movements and subsequent exposure while implanted. Neoss Ti Reinforced Membrane is provided pre-shaped in a variety of shapes and sizes detailed below. The device is supplied sterile and single use.
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    K Number
    K132325
    Device Name
    GUIDOR BIORESORBABLE MATRIX BARRIER
    Manufacturer
    SUNSTAR AMERICAS, INC.
    Date Cleared
    2013-10-29

    (95 days)

    Product Code
    NPK
    Regulation Number
    872.3930
    Why did this record match?
    Product Code :

    NPK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GBR Configurations: To aid in bone regeneration and augmentation in oral surgery for: Extraction socket site preservation; Immediate implant placement at time of extraction or delayed placement when additional bone regeneration is desire; Ridge augmentation; Sinus elevation; Stable barrier for the containment of bone grafting materials. GTR Configurations: To aid in the regeneration and integration of periodontal tissue components. For use as an adjunct in periodontal surgical treatment to supplement the reparative process following scaling and root planning for: Class II furcations; intrabony defects; recession type defects.
    Device Description
    The GUIDOR® Bioresorbable Matrix Barrier is a two-layered (sandwich) structure with spacers between the layers that provide stability to the matrix and maintain an adequate space to aid in tissue regeneration and prevention of epithelial downgrowth. The GUIDOR® Matrix is bioresorbable to allow for singlestep surgery, eliminating the need for a second surgery to remove the matrix.
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