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510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    Unicare Biomedical, Inc.

    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
    K092567
    Device Name
    MODIFICATION TO UNIGRAFT
    Manufacturer
    UNICARE BIOMEDICAL, INC.
    Date Cleared
    2009-11-25

    (97 days)

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

    UNICARE BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Unigraft® is indicated for the repair of dental intraosseous and oral/maxillofacial defects, including: augmentation of the alveolar ridge, filling of infrabony periodontal defects, filling of extraction sockets to enhance preservation of the alveolar ridge, elevation of the maxillary sinus floor, filling of defects after cystectomy, apicoectomy and root resection, filling of periodontal and peri-implant defects in conjunction with products intended for GTR and GBR procedures, and filling of maxillofacial osseous cavities
    Device Description
    Unigraft is a synthetic bioactive glass that is intended for use in the repair of oral/maxillofacial and dental intraosseous defects. The bioactive glass granules are supplied sterile in a polyolefin vial within a sealed pouch.
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    K Number
    K090083
    Device Name
    CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090
    Manufacturer
    UNICARE BIOMEDICAL, INC.
    Date Cleared
    2009-03-23

    (70 days)

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

    UNICARE BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CytoFlex® Resorb membranes are intended for use as a space-making barrier in the treatment of periodontal defects and maxillofacial guided tissue regeneration procedures, including preservation and regeneration of alveolar bone height and volume, ridge and extraction site augmentation, sinus lifts, and treatment of associated cystic defects. It is also intended for use as a grafting material containment matrix.
    Device Description
    CytoFlex® Resorb barriers are made from polyglycolide, polylactide and poly(glycolide-co-lactide) copolymer. CytoFlex® Resorb is a resorbable barrier membrane and is supplied in a variety of shapes and sizes in sealed pouches. CytoFlex® Resorb membrane is tested, evaluated and found to be substantially equivalent to legally marketed predicate devices.
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    K Number
    K080532
    Device Name
    BENACEL, MODELS C-001, C-002 AND C-005
    Manufacturer
    UNICARE BIOMEDICAL, INC.
    Date Cleared
    2008-11-12

    (260 days)

    Product Code
    QSY
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNICARE BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    Not Found
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    K Number
    K021511
    Device Name
    CYTOFLEX MESH
    Manufacturer
    UNICARE BIOMEDICAL, INC.
    Date Cleared
    2002-08-06

    (89 days)

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

    UNICARE BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use to ensure three-dimensional reconstruction of alveolar bone defects and to facilitate augmentation with adequate fixation of the augmentation material.
    Device Description
    Cytoflex Mesh is a precision titanium mesh of a specific dimension and pore size. Cytoflex Mesh is supplied in specific sizes and thickness in sealed pouches. Cytoflex Mesh is tested, evaluated and found to be substantially equivalent to legally marketed predicate devices.
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    K Number
    K020720
    Device Name
    OSSIFORM
    Manufacturer
    UNICARE BIOMEDICAL, INC.
    Date Cleared
    2002-05-07

    (63 days)

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

    UNICARE BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ossiform is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects including: periodontal defects, ridge augmentation, extraction sites, cranio-facial augmentation, sinus lifts and cystic defects
    Device Description
    Ossiform is a synthetic bioactive glass that is intended for use in the repair of oral/maxillofacial and dental intraosseous defects. The bioactive glass granules are supplied sterile in a polyolefin vial within a sealed pouch.
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    K Number
    K012144
    Device Name
    CYTOFLEX
    Manufacturer
    UNICARE BIOMEDICAL, INC.
    Date Cleared
    2001-10-01

    (83 days)

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

    UNICARE BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.
    Device Description
    CytoFlex™ is a non-resorbable barrier membrane that is composed of microporous ePTFE material. The sterile membrane has a nominal thickness of 250 microns and is supplied in a variety of shapes and sizes in sealed pouches. The biocompatibility of ePTFE has been established through a long history of use in a variety of implant applications. CytoFlex™ membrane is tested, evaluated and found to be substantially equivalent to legally marketed predicate devices.
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