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510(k) Data Aggregation
K Number
K151344Device Name
Cytoflex Tefguard Ti-Enforced Membrane
Manufacturer
Unicare Biomedical, Inc.
Date Cleared
2015-11-19
(184 days)
Product Code
NPK
Regulation Number
872.3930Why 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
K092567Device Name
MODIFICATION TO UNIGRAFT
Manufacturer
UNICARE BIOMEDICAL, INC.
Date Cleared
2009-11-25
(97 days)
Product Code
LYC
Regulation Number
872.3930Why 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
K090083Device 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
872.3930Why 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
K080532Device 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/AWhy 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
K021511Device Name
CYTOFLEX MESH
Manufacturer
UNICARE BIOMEDICAL, INC.
Date Cleared
2002-08-06
(89 days)
Product Code
JEY
Regulation Number
872.4760Why 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
K020720Device Name
OSSIFORM
Manufacturer
UNICARE BIOMEDICAL, INC.
Date Cleared
2002-05-07
(63 days)
Product Code
LYC
Regulation Number
872.3930Why 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
K012144Device Name
CYTOFLEX
Manufacturer
UNICARE BIOMEDICAL, INC.
Date Cleared
2001-10-01
(83 days)
Product Code
LYC
Regulation Number
872.3930Why 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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