UNICARE BIOMEDICAL, INC.

Matched from indexed company URL: Unicare Biomedical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20325423003646540UNICARE BIOMEDICAL, INC.1N2026-01-0123011 Moulton Pkwy Ste J11 Laguna Hills CA US 92653

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
D767C0635010Perforated Cytoflex Ti-enforced - Perforated Ti-Enforced® membranes are made of the same materials and features as Cytoflex® Ti-Enforced® membranes with the exception of perforation. The perforated macro holes allow for direct vascularization across the membrane. Both the Ti-Enforced® and perforated Ti-Enforced® membranes are designed to achieve predictable outcomes for GBR procedures.949-305-9600sales@unicarebiomedical.com
D767C0639010Perforated Cytoflex Ti-enforced - Perforated Ti-Enforced® membranes are made of the same materials and features as Cytoflex® Ti-Enforced® membranes with the exception of perforation. The perforated macro holes allow for direct vascularization across the membrane. Both the Ti-Enforced® and perforated Ti-Enforced® membranes are designed to achieve predictable outcomes for GBR procedures.949-305-9600sales@unicarebiomedical.com
D767C0641010Perforated Cytoflex Ti-enforced - Perforated Ti-Enforced® membranes are made of the same materials and features as Cytoflex® Ti-Enforced® membranes with the exception of perforation. The perforated macro holes allow for direct vascularization across the membrane. Both the Ti-Enforced® and perforated Ti-Enforced® membranes are designed to achieve predictable outcomes for GBR procedures.949-305-9600sales@unicarebiomedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
551581660920284K200623OssGuideNPL2020-10-02
551581990310161K151344Cytoflex Tefguard Ti-Enforced MembraneNPK2015-11-19
551581986655315K100927SURGIAIDKGN2011-02-02
551581588460234K092567MODIFICATION TO UNIGRAFTLYC2009-11-25
551581028016369K090612BENACELOLR2009-07-24
551581480571649K090083CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090LYC2009-03-23
551581167418266K080532BENACEL, MODELS C-001, C-002 AND C-005QSY2008-11-12
551581139061752K021511CYTOFLEX MESHJEY2002-08-06
551581508394006K012144CYTOFLEXLYC2001-10-01

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LYC32009-11-25
NPL12020-10-02
NPK12015-11-19
KGN12011-02-02
OLR12009-07-24
QSY12008-11-12
JEY12002-08-06

PMN#

BENACEL

2009-07-24

UNICARE BIOMEDICAL

CYTOFLEX

2001-10-01

UNICARE BIOMEDICAL, INC.

GUDID#

Benacel Plus - BenaCel® Plus Hemostatic Dressing is provided in larger sizes for medical use. Made of biocompatible oxidized cellulose, BenaCel® Plus is intended for the temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, donor sites, dermatological, etc.) and traumatic injuries. It may also be used as a topical dressing for local management of bleeding wounds such as lacerations, cuts and abrasions. Approximate resorption time is 2 weeks.

UNICARE BIOMEDICAL INC.

2024-07-12

Benacel Plus - BenaCel® Plus Hemostatic Dressing is provided in larger sizes for medical use. Made of biocompatible oxidized cellulose, BenaCel® Plus is intended for the temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, donor sites, dermatological, etc.) and traumatic injuries. It may also be used as a topical dressing for local management of bleeding wounds such as lacerations, cuts and abrasions. Approximate resorption time is 2 weeks.

UNICARE BIOMEDICAL INC.

2024-07-12

Benacel Plus - BenaCel® Plus Hemostatic Dressing is provided in larger sizes for medical use. Made of biocompatible oxidized cellulose, BenaCel® Plus is intended for the temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, donor sites, dermatological, etc.) and traumatic injuries. It may also be used as a topical dressing for local management of bleeding wounds such as lacerations, cuts and abrasions. Approximate resorption time is 2 weeks.

UNICARE BIOMEDICAL INC.

2024-07-12

Benacel Plus - BenaCel® Plus Hemostatic Dressing is provided in larger sizes for medical use. Made of biocompatible oxidized cellulose, BenaCel® Plus is intended for the temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, donor sites, dermatological, etc.) and traumatic injuries. It may also be used as a topical dressing for local management of bleeding wounds such as lacerations, cuts and abrasions. Approximate resorption time is 2 weeks.

UNICARE BIOMEDICAL INC.

2024-07-12

Benacel Plus - BenaCel® Plus Hemostatic Dressing is provided in larger sizes for medical use. Made of biocompatible oxidized cellulose, BenaCel® Plus is intended for the temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, donor sites, dermatological, etc.) and traumatic injuries. It may also be used as a topical dressing for local management of bleeding wounds such as lacerations, cuts and abrasions. Approximate resorption time is 2 weeks.

UNICARE BIOMEDICAL INC.

2024-07-12

Benacel Plus - BenaCel® Plus Hemostatic Dressing is provided in larger sizes for medical use. Made of biocompatible oxidized cellulose, BenaCel® Plus is intended for the temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, donor sites, dermatological, etc.) and traumatic injuries. It may also be used as a topical dressing for local management of bleeding wounds such as lacerations, cuts and abrasions. Approximate resorption time is 2 weeks.

UNICARE BIOMEDICAL INC.

2024-07-12

Cytoflex Ti-enforced - Ti-Enforced® ePTFE 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 barrier material with a titanium frame enclosed within two layers of ePTFE material. The titanium reinforcement is intended for space and shape maintenance to contain bone grafting material and to minimize graft movement during wound healing. The membranes are designed to block bacteria penetration, and impede the migration and establishment of gingival tissue derived cells into bony defects. This provides a more favorable environment for neovascularization and for bone derived cells to repopulate and repair the defect. The Ti-Enforced® membranes are textured on both surfaces to improve handling and adhesion between tissue and membrane.

UNICARE BIOMEDICAL INC.

2024-01-10

Cytoflex Ti-enforced - Ti-Enforced® ePTFE 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 barrier material with a titanium frame enclosed within two layers of ePTFE material. The titanium reinforcement is intended for space and shape maintenance to contain bone grafting material and to minimize graft movement during wound healing. The membranes are designed to block bacteria penetration, and impede the migration and establishment of gingival tissue derived cells into bony defects. This provides a more favorable environment for neovascularization and for bone derived cells to repopulate and repair the defect. The Ti-Enforced® membranes are textured on both surfaces to improve handling and adhesion between tissue and membrane.

UNICARE BIOMEDICAL INC.

2024-01-10

Cytoflex Ti-enforced - Ti-Enforced® ePTFE 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 barrier material with a titanium frame enclosed within two layers of ePTFE material. The titanium reinforcement is intended for space and shape maintenance to contain bone grafting material and to minimize graft movement during wound healing. The membranes are designed to block bacteria penetration, and impede the migration and establishment of gingival tissue derived cells into bony defects. This provides a more favorable environment for neovascularization and for bone derived cells to repopulate and repair the defect. The Ti-Enforced® membranes are textured on both surfaces to improve handling and adhesion between tissue and membrane.

UNICARE BIOMEDICAL INC.

2024-01-10

Cytoflex Ti-enforced - Ti-Enforced® ePTFE 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 barrier material with a titanium frame enclosed within two layers of ePTFE material. The titanium reinforcement is intended for space and shape maintenance to contain bone grafting material and to minimize graft movement during wound healing. The membranes are designed to block bacteria penetration, and impede the migration and establishment of gingival tissue derived cells into bony defects. This provides a more favorable environment for neovascularization and for bone derived cells to repopulate and repair the defect. The Ti-Enforced® membranes are textured on both surfaces to improve handling and adhesion between tissue and membrane.

UNICARE BIOMEDICAL INC.

2024-01-10

Cytoflex Ti-enforced - Ti-Enforced® ePTFE 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 barrier material with a titanium frame enclosed within two layers of ePTFE material. The titanium reinforcement is intended for space and shape maintenance to contain bone grafting material and to minimize graft movement during wound healing. The membranes are designed to block bacteria penetration, and impede the migration and establishment of gingival tissue derived cells into bony defects. This provides a more favorable environment for neovascularization and for bone derived cells to repopulate and repair the defect. The Ti-Enforced® membranes are textured on both surfaces to improve handling and adhesion between tissue and membrane.

UNICARE BIOMEDICAL INC.

2024-01-10

Cytoflex Ti-enforced - Ti-Enforced® ePTFE 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 barrier material with a titanium frame enclosed within two layers of ePTFE material. The titanium reinforcement is intended for space and shape maintenance to contain bone grafting material and to minimize graft movement during wound healing. The membranes are designed to block bacteria penetration, and impede the migration and establishment of gingival tissue derived cells into bony defects. This provides a more favorable environment for neovascularization and for bone derived cells to repopulate and repair the defect. The Ti-Enforced® membranes are textured on both surfaces to improve handling and adhesion between tissue and membrane.

UNICARE BIOMEDICAL INC.

2024-01-10

Cytoflex Ti-enforced - Ti-Enforced® ePTFE 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 barrier material with a titanium frame enclosed within two layers of ePTFE material. The titanium reinforcement is intended for space and shape maintenance to contain bone grafting material and to minimize graft movement during wound healing. The membranes are designed to block bacteria penetration, and impede the migration and establishment of gingival tissue derived cells into bony defects. This provides a more favorable environment for neovascularization and for bone derived cells to repopulate and repair the defect. The Ti-Enforced® membranes are textured on both surfaces to improve handling and adhesion between tissue and membrane.

UNICARE BIOMEDICAL INC.

2024-01-10

Cytoflex Ti-enforced - Ti-Enforced® ePTFE 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 barrier material with a titanium frame enclosed within two layers of ePTFE material. The titanium reinforcement is intended for space and shape maintenance to contain bone grafting material and to minimize graft movement during wound healing. The membranes are designed to block bacteria penetration, and impede the migration and establishment of gingival tissue derived cells into bony defects. This provides a more favorable environment for neovascularization and for bone derived cells to repopulate and repair the defect. The Ti-Enforced® membranes are textured on both surfaces to improve handling and adhesion between tissue and membrane.

UNICARE BIOMEDICAL INC.

2024-01-10

Cytoflex Ti-enforced - Ti-Enforced® ePTFE 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 barrier material with a titanium frame enclosed within two layers of ePTFE material. The titanium reinforcement is intended for space and shape maintenance to contain bone grafting material and to minimize graft movement during wound healing. The membranes are designed to block bacteria penetration, and impede the migration and establishment of gingival tissue derived cells into bony defects. This provides a more favorable environment for neovascularization and for bone derived cells to repopulate and repair the defect. The Ti-Enforced® membranes are textured on both surfaces to improve handling and adhesion between tissue and membrane.

UNICARE BIOMEDICAL INC.

2024-01-10

Cytoflex Ti-enforced - Ti-Enforced® ePTFE 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 barrier material with a titanium frame enclosed within two layers of ePTFE material. The titanium reinforcement is intended for space and shape maintenance to contain bone grafting material and to minimize graft movement during wound healing. The membranes are designed to block bacteria penetration, and impede the migration and establishment of gingival tissue derived cells into bony defects. This provides a more favorable environment for neovascularization and for bone derived cells to repopulate and repair the defect. The Ti-Enforced® membranes are textured on both surfaces to improve handling and adhesion between tissue and membrane.

UNICARE BIOMEDICAL INC.

2024-01-10

Cytoflex Ti-enforced - Ti-Enforced® ePTFE 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 barrier material with a titanium frame enclosed within two layers of ePTFE material. The titanium reinforcement is intended for space and shape maintenance to contain bone grafting material and to minimize graft movement during wound healing. The membranes are designed to block bacteria penetration, and impede the migration and establishment of gingival tissue derived cells into bony defects. This provides a more favorable environment for neovascularization and for bone derived cells to repopulate and repair the defect. The Ti-Enforced® membranes are textured on both surfaces to improve handling and adhesion between tissue and membrane.

UNICARE BIOMEDICAL INC.

2024-01-10

BenaCel - BenaCel® dental dressing is made of biocompatible oxidized cellulose and contains no chemical additives. BenaCel® dental dressing adheres to moist oral mucosa and forms a temporary barrier protecting the wound from further irritation and pain. When placed in the extraction socket, BenaCel® dental dressing forms a gelatinous scaffold in the blood extrude, facilitating the development of a stable blood clot to prevent dry socket formation. BenaCel® dental dressing is designed for use in the extraction site and the management of bleeding and alveolar osteitis (dry socket). It may also be used as a wound dressing for the temporary management of oral surgical wounds, such as operative, postoperative, donor sites and traumatic injuries.

UNICARE BIOMEDICAL INC.

2021-07-23

BenaCel - BenaCel® dental dressing is made of biocompatible oxidized cellulose and contains no chemical additives. BenaCel® dental dressing adheres to moist oral mucosa and forms a temporary barrier protecting the wound from further irritation and pain. When placed in the extraction socket, BenaCel® dental dressing forms a gelatinous scaffold in the blood extrude, facilitating the development of a stable blood clot to prevent dry socket formation. BenaCel® dental dressing is designed for use in the extraction site and the management of bleeding and alveolar osteitis (dry socket). It may also be used as a wound dressing for the temporary management of oral surgical wounds, such as operative, postoperative, donor sites and traumatic injuries.

UNICARE BIOMEDICAL INC.

2021-07-23

Unigraft - Unigraft is made of synthetic bioactive glass material. The product is conveniently packaged in a sterile vial and stored within a hermetically sealed foil pouch to ensure product sterility prior to implantation. Unigraft offers an osteogenic framework for new bone growth and bolsters a higher level of osteoblastic activity to enhance bone regeneration. FDA has cleared this product for use in treating periodontal defects, extractions sites, sinus elevation, apicoectomy and root resection, cranial and facial augmentation and augmentation of the alveolar ridges.

UNICARE BIOMEDICAL INC.

2015-09-18

Unigraft - Unigraft is made of synthetic bioactive glass material. The product is conveniently packaged in a sterile vial and stored within a hermetically sealed foil pouch to ensure product sterility prior to implantation. Unigraft offers an osteogenic framework for new bone growth and bolsters a higher level of osteoblastic activity to enhance bone regeneration. FDA has cleared this product for use in treating periodontal defects, extractions sites, sinus elevation, apicoectomy and root resection, cranial and facial augmentation and augmentation of the alveolar ridges.

UNICARE BIOMEDICAL INC.

2015-09-18

Unigraft - Unigraft is made of synthetic bioactive glass material. The product is conveniently packaged in a sterile vial and stored within a hermetically sealed foil pouch to ensure product sterility prior to implantation. Unigraft offers an osteogenic framework for new bone growth and bolsters a higher level of osteoblastic activity to enhance bone regeneration. FDA has cleared this product for use in treating periodontal defects, extractions sites, sinus elevation, apicoectomy and root resection, cranial and facial augmentation and augmentation of the alveolar ridges.

UNICARE BIOMEDICAL INC.

2015-09-18

Unigraft - Unigraft is made of synthetic bioactive glass material. The product is conveniently packaged in a sterile vial and stored within a hermetically sealed foil pouch to ensure product sterility prior to implantation. Unigraft offers an osteogenic framework for new bone growth and bolsters a higher level of osteoblastic activity to enhance bone regeneration. FDA has cleared this product for use in treating periodontal defects, extractions sites, sinus elevation, apicoectomy and root resection, cranial and facial augmentation and augmentation of the alveolar ridges.

UNICARE BIOMEDICAL INC.

2015-09-18

Cytoflex Textured Tef-Guard - Cytoflex® Tef-Guard® is a non-resorbable membrane for use as a space-making barrier in guided tissue regeneration procedures. Composed of a proprietary micro-porous polytetrafluoroethylene (ePTFE) thin film, Cytoflex® Tef-Guard® has a surface texture and porosity suitable for adhesion of host cells to the material while blocking passage and integration of bacteria within the interstices of the material. The supple membrane conforms easily to tissue contours, and yet offers sufficient stiffness to maintain a space over the bony defect. The micro porous surface is designed to improve flap attachment but prevent tissue and bacteria ingrowth. Cytoflex® Tef-Guard® is for use as a barrier membrane for guided tissue regeneration procedures. Composed of a proprietary micro-porous polytetrafluoroethylene (ePTFE), the textured version of Cytoflex® Tef-Guard® has superficial macro texture overlapping the micro pore texture on both surfaces. The cellular level micro texture is invisible to the naked eye, but can be seen at high magnifications. The macro texture provides additional grips for flap attachment.

UNICARE BIOMEDICAL INC.

2016-11-23

Cytoflex Textured Tef-Guard - Cytoflex® Tef-Guard® is a non-resorbable membrane for use as a space-making barrier in guided tissue regeneration procedures. Composed of a proprietary micro-porous polytetrafluoroethylene (ePTFE) thin film, Cytoflex® Tef-Guard® has a surface texture and porosity suitable for adhesion of host cells to the material while blocking passage and integration of bacteria within the interstices of the material. The supple membrane conforms easily to tissue contours, and yet offers sufficient stiffness to maintain a space over the bony defect. The micro porous surface is designed to improve flap attachment but prevent tissue and bacteria ingrowth. Cytoflex® Tef-Guard® is for use as a barrier membrane for guided tissue regeneration procedures. Composed of a proprietary micro-porous polytetrafluoroethylene (ePTFE), the textured version of Cytoflex® Tef-Guard® has superficial macro texture overlapping the micro pore texture on both surfaces. The cellular level micro texture is invisible to the naked eye, but can be seen at high magnifications. The macro texture provides additional grips for flap attachment.

UNICARE BIOMEDICAL INC.

2016-11-23

Cytoflex Resorb - Cytoflex® Resorb is a synthetic, microporous resorbable barrier membrane. Cytoflex® Resorb membranes are designed to enhance the adhesion of host cells, and at the same time provide a favorable environment for neo-vascularization and repopulation of bone cells to regenerate osseous tissue. The flexible barrier membranes are easily adaptable to tissue contours, yet offer sufficient duration to protect the bony defect from the intrusion of bacteria and soft tissue. Composed of synthetic polylactide and polyglycolide copolymers, Cytoflex® Resorb barriers are resorbable and do not require a second retrieval procedure.

UNICARE BIOMEDICAL INC.

2015-09-24

Cytoflex Resorb - Cytoflex® Resorb is a synthetic, microporous resorbable barrier membrane. Cytoflex® Resorb membranes are designed to enhance the adhesion of host cells, and at the same time provide a favorable environment for neo-vascularization and repopulation of bone cells to regenerate osseous tissue. The flexible barrier membranes are easily adaptable to tissue contours, yet offer sufficient duration to protect the bony defect from the intrusion of bacteria and soft tissue. Composed of synthetic polylactide and polyglycolide copolymers, Cytoflex® Resorb barriers are resorbable and do not require a second retrieval procedure.

UNICARE BIOMEDICAL INC.

2015-09-24

Cytoflex Resorb - Cytoflex® Resorb is a synthetic, microporous resorbable barrier membrane. Cytoflex® Resorb membranes are designed to enhance the adhesion of host cells, and at the same time provide a favorable environment for neo-vascularization and repopulation of bone cells to regenerate osseous tissue. The flexible barrier membranes are easily adaptable to tissue contours, yet offer sufficient duration to protect the bony defect from the intrusion of bacteria and soft tissue. Composed of synthetic polylactide and polyglycolide copolymers, Cytoflex® Resorb barriers are resorbable and do not require a second retrieval procedure.

UNICARE BIOMEDICAL INC.

2015-09-24

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