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510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    Osteogenics Biomedical, Inc.

    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?
    Applicant Name (Manufacturer) :

    Osteogenics Biomedical, Inc.

    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
    K141177
    Device Name
    VITALA PORCINE DERIVED COLLAGEN MEMBRANE
    Manufacturer
    OSTEOGENICS BIOMEDICAL, INC. (FORMERLY OBI BIOLOGI
    Date Cleared
    2015-09-15

    (496 days)

    Product Code
    NPL
    Regulation Number
    872.3930
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTEOGENICS BIOMEDICAL, INC. (FORMERLY OBI BIOLOGI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vitala® Porcine Derived Collagen Membrane is intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for: -Simultaneous use with implants; -Augmentation around implants placed in immediate extraction sockets; -Augmentation around implants placed in delayed extraction sockets; -Localized ridge augmentation for later implantation; -Alveolar ridge reconstruction for prosthetic treatment; -Alveolar ridge preservation consequent to tooth extraction; -Filling of bone defects after root resection, cystectomy, removal of retained teeth; -Over the window in lateral window sinus elevation procedures; -Furcation defects in multi-rooted teeth; -Treatment of recession defects, together with coronally positioned flap; -In implants with vertical bone loss due to infection, only with satisfactory debridement and implant surface disinfection; -Guided bone regeneration in dehiscence defects; and -Guided tissue regeneration in periodontal defects.
    Device Description
    Vitala® Porcine Derived Collagen Membrane is a natural collagen membrane for use in periodontal and/or dental surgical procedures. The membrane is manufactured using a standardized, controlled, multistage process. The pre-slaughter origin of all animals is the United States of America and the source collagen is extracted from veterinary-certified pigs sacrificed in a USDA-inspected facility. The membrane is terminally sterilized in double blister packs by electron beam irradiation. The contents of the unopened, undamaged inner package are sterile. Vitala® Porcine Derived Collagen Membrane functions as a barrier when applied between bone graft material and soft tissue. The membrane serves as a bioresorbable scaffold that is eventually remodeled and replaced by host tissue. Animal studies have shown that Vitala® Porcine Derived Collagen Membrane is substantially resorbed by 26 weeks.
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    K Number
    K093719
    Device Name
    PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT#
    Manufacturer
    OSTEOGENICS BIOMEDICAL, INC.
    Date Cleared
    2010-03-01

    (89 days)

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

    OSTEOGENICS BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pro-Fix™ Precision Fixation System is used to stabilize, fixate and/or support bone grafts, bone filling materials and/or barrier membranes used for regeneration of bone in the oral cavity.
    Device Description
    Not Found
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    K Number
    K072076
    Device Name
    CYTOPLAST PTFE SUTURE
    Manufacturer
    OSTEOGENICS BIOMEDICAL, INC.
    Date Cleared
    2007-10-31

    (93 days)

    Product Code
    NBY
    Regulation Number
    878.5035
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTEOGENICS BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cytoplast® PTFE Suture is indicated for use in all types of soft tissue approximation and/or ligation, including cardiovascular, dental and general surgeries, as well as repair of the dura mater. The device is not indicated for use in ophthalmic surgery, microsurgery and peripheral neural tissue.
    Device Description
    Not Found
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    K Number
    K013764
    Device Name
    IMMIX BONE GRAFT EXTENDER
    Manufacturer
    OSTEOGENICS BIOMEDICAL, INC.
    Date Cleared
    2002-05-16

    (184 days)

    Product Code
    KKY, LYC
    Regulation Number
    878.3500
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTEOGENICS BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    As a spacemaking device used in guided bone regeneration. Treatment of bony defects, ridge maintenance, alveolar socket preservation or ridge augmentation. As a spacemaking device used in cranio-facial guided bone regeneration. Treatment of bony defects, ridge maintenance, alveolar socket preservation or ridge augmentation. Not to be used in load-bearing areas.
    Device Description
    Immix™ is a DL-polylactide resorbable polymer material intended for use by itself or in combination with other materials to create space for bone regeneration. The material is packaged individually in various amounts and supplied sterile.
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    K Number
    K003028
    Device Name
    CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC
    Manufacturer
    OSTEOGENICS BIOMEDICAL, INC.
    Date Cleared
    2000-11-24

    (57 days)

    Product Code
    NBY
    Regulation Number
    878.5035
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTEOGENICS BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993610
    Device Name
    CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250
    Manufacturer
    OSTEOGENICS BIOMEDICAL, INC.
    Date Cleared
    2000-03-02

    (129 days)

    Product Code
    LYC
    Regulation Number
    872.3930
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTEOGENICS BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    As a space-making barrier in the treatment of periodontal defects and guided tissue regeneration procedures; As a grafting material containment membrane.
    Device Description
    Cytoplast™ Resorb is a bioresorbable material. Specifically, the device is designed to be biocompatible, cell occlusive, spacemaking, and clinically manageable. The product is supplied sterile and packaged individually in various sizes.
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    K Number
    K984230
    Device Name
    OSTEO-MESH TM-300
    Manufacturer
    OSTEOGENICS BIOMEDICAL, INC.
    Date Cleared
    1999-02-04

    (71 days)

    Product Code
    JEY
    Regulation Number
    872.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTEOGENICS BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For stabilization and support of bone grafts in dento-alveolar bony defect sites.
    Device Description
    The Osteo-Mesh ™ TM-300 titanium ridge augmentation mesh is fabricated from Grade 1 titanium as described by ASTM-F-67 or its ISO equivalent. The Osteo-Mesh™ TM-300is supplied nonsterile in two sizes: 25 mm x 30 mm and 12 mm x 25 mm. The biocompatibility of titanium has been established through a long history of use in a variety of implant devices. No additional biocompatibility testing has been performed with this device.
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