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Found 11 results
510(k) Data Aggregation
K Number
K151344Device Name
Cytoflex Tefguard Ti-Enforced Membrane
Manufacturer
Date Cleared
2015-11-19
(184 days)
Product Code
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
Unicare Biomedical, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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
K092567Device Name
MODIFICATION TO UNIGRAFT
Manufacturer
Date Cleared
2009-11-25
(97 days)
Product Code
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
UNICARE BIOMEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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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Applicant Name (Manufacturer) :
UNICARE BIOMEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Benacel® Dental Dressing is intended for use as a wound dressing in extraction sites and the management of alveolar osteitis (dry socket) and may be used as a wound dressing for the temporary management of oral surgical wounds, such as operative, postoperative, donor sites, and traumatic injuries. Benacel® Dental Dressing may also be used as a wound dressing for the management and protection of oral lesions, including sores, ulcers, and injuries, such as cuts, lacerations and abrasions of the oral mucosa.
Device Description
Benacel® Dental Dressing is an absorbable wound dressing made of oxidized regenerated cellulose material. Upon contact with moist oral mucosa, the material dissolves and transforms into a gelatinous material. By applying gentle pressure at this time, the material will adhere to the wound and form a barrier, protecting the wound from further irritation and pain. Benacel® Dental Dressing is sterile packaged and supplied in a variety of configurations and sizes.
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K Number
K090083Device Name
CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090
Manufacturer
Date Cleared
2009-03-23
(70 days)
Product Code
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
UNICARE BIOMEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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
K080532Device Name
BENACEL, MODELS C-001, C-002 AND C-005
Manufacturer
Date Cleared
2008-11-12
(260 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
UNICARE BIOMEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Not Found
Device Description
Not Found
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K Number
K021511Device Name
CYTOFLEX MESH
Manufacturer
Date Cleared
2002-08-06
(89 days)
Product Code
Regulation Number
872.4760Why did this record match?
Applicant Name (Manufacturer) :
UNICARE BIOMEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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
K020720Device Name
OSSIFORM
Manufacturer
Date Cleared
2002-05-07
(63 days)
Product Code
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
UNICARE BIOMEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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
K012144Device Name
CYTOFLEX
Manufacturer
Date Cleared
2001-10-01
(83 days)
Product Code
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
UNICARE BIOMEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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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K Number
K003457Device Name
UNIGRAFT
Manufacturer
Date Cleared
2001-01-09
(63 days)
Product Code
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
UNICARE BIOMEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K993784Device Name
UNIGRAFT
Manufacturer
Date Cleared
2000-01-27
(80 days)
Product Code
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
UNICARE BIOMEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For the repair of periodontal infrabony defects, extraction site and augmentation of the alveolar ridge
Device Description
Unigraft is a synthetic bioactive glass material for use in the repair of oral defects, including periodontal defects, extraction sites and augmentation of the alveolar ridge. It is manufactured as irregular shaped synthetic granules, sized at 200-420 microns.
The bioactive glass (45S5 Bioglass) used in Unigraft is one of the most extensively studied bioactive glass compositions, which has been shown to bond to bone as well as soft tissue. The same material is used in legally marketed devices, including BioGran® and PerioGlas®. When implanted in the living tissue, the material undergoes a time dependent surface modification. The surface reaction results in the formation of a calcium phosphate layer, which is equivalent in composition and structure to the hydroxyapatite found in bone minerals. The biological apatite layer of the granules provides an osteo-conductive scaffold for the generation of new osseous tissue.
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