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SwissGraft X is intended for the following uses: - augmentation or reconstructive treatment of the alveolar ridge - filling of infrabony periodontal defects - filling of defects after root resection, apicoectomy, and cystectomy - filling of extraction sockets to enhance preservation of the alveolar ridge - elevation of the maxillary sinus floor - filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) - filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

SwissGraft X is a biocompatible bone mineral matrix and is manufactured from purified spongiosa (cancellous) bovine bone mineral granules. SwissGraft X serves as a matrix consisting of interconnected macro- and micropores. The material is highly porous, hydrophilic, and has a large inner surface area. SwissGraft X is sterilized by x-ray irradiation. SwissGraft X is provided in granule form.

SwissMembrane X is intended for the following uses: - 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; - filling of bone defects after root resection, cystectomy, removal of retained teeth; - guided bone regeneration in dehiscence defects; and - guided tissue regeneration procedures in periodontal defects. SwissMembrane X Socket is intended for the following uses: - 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; - filling of bone defects after root resection, cystectomy, removal of retained teeth; - guided bone regeneration in dehiscence defects.

SwissMembrane X and SwissMembrane X Socket are resorbable collagen membranes made of porcine collagen. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membranes are made of collagen without further cross-linking and are sterilized by gamma irradiation. SwissMembrane X is provided in the following variants and sizes: - SwissMembrane X D-Line - 13 x 25 mm (rectangle) - 25 x 15/25 mm (trapezoid) - 30 x 25/40 mm (trapezoid) - SwissMembrane X Socket D-Line - 14 x 24 mm

Geistlich Bio-Flow® is intended for bone regeneration of contained defects around teeth or dental implants for the following uses: 1. filling of extraction sockets to enhance preservation of the alveolar ridge in contained situations with entirely intact, circumferential bone walls. 2. filling of contained periodontal defects of limited size with intact lingual and buccal walls, i.e. 3-wall intrabony defects. 3. filling of contained peri-implant defects of limited size to include 3-wall defects of a size up to 4 mm x 5 mm x 4 mm.

Geistlich Bio-Flow® is a flowable, sterile, biocompatible bone mineral plus collagen matrix consisting of Geistlich Bio-Oss® granules (K122894) and processed Geistlich Bio-Gide® collagen (K212463) in an 80:20 (dry weight) ratio. Geistlich Bio-Flow® is provided as dry granulated material pre-filled in a mixing syringe (0.2 cc or 0.5 cc fill volumes). Cannulas and a syringe for applying saline or blood to hydrate the product prior to extrusion are included with the product.

Device 300397 Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Device 300397 Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, ilium and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. Device 300397 Putty must be used with blood or autogenous bone marrow aspirate and autograff in posterolateral spine.

Device 300397 Putty is an osteoconductive, porous, resorbable bone graft substitute which consists of calcium phosphate granules (a-TCP and hydroxyapatite) and Type I and III porcine collagen. The single-patient, single-use product is supplied in three (3) sizes as a sterile, dry block. When mixed with autogenous bone marrow aspirate, blood or sterile non-pyrogenic saline, the product forms a moldable non-setting putty (net volume: 2.5 cc, 5 cc or 10 cc).

Geistlich Bio-Oss® is intended for the following uses: - Augmentation or reconstructive treatment of the alveolar ridge; - Filling of infrabony periodontal defects; - Filling of defects after root resection, apicoectomy, and cystectomy; - Filling of extraction sockets to enhance preservation of the alveolar ridge; - Elevation of the maxillary sinus floor; - Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and - Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

Geistlich Bio-Oss® is a biocompatible bone mineral matrix and is manufactured from purified spongiosa (cancellous) bovine bone mineral. The product is provided in granules or block form. Geistlich Bio-Oss® serves as a matrix consisting of interconnected macro- and micropores. The material is highly porous, hydrophilic and has a large inner surface area. Geistlich Bio-Oss® is provided sterile via gamma irradiation or x-ray irradiation.

Wound Matrix PLUS is intended for the management of wounds including: - Partial and full-thickness wounds - Pressure ulcers - Venous ulcers - Diabetic ulcers - Chronic vascular ulcers - Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) - Trauma wounds (abrasions, lacerations,second-degree burns, and skin tears) - Draining wounds - Tunneled/undermined wounds The device is intended for one-time use.

Geistlich Wound Matrix PLUS is an animal-sourced, acellular extracellular matrix (ECM) wound dressing that is derived from porcine tissue. The porcine tissue undergoes processing to remove proteins and inactivate viruses. The device is intended for use in the management of wounds. Wound Matrix PLUS is terminally sterilized using gamma irradiation in its packaging. The device is offered in various sizes and can be shaped to the required dimension using standard sterile instruments (scissors or scalpel). The device is intended to be used by licensed healthcare practitioners and will be supplied sterile for single one-time use.

Geistlich Bio-Gide® is intended for the following uses: - 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; - filling of bone defects after root resection, cystectomy, removal of retained teeth; - guided bone regeneration in dehiscence defects; and - guided tissue regeneration procedures in periodontal defects. Geistlich Bio-Gide® Compressed is indicated for: - 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. - filling of bone defects after root resection, cystectomy, removal of retained teeth. - guided bone regeneration in dehiscence defects, and - guided tissue regeneration procedures in periodontal teeth. Geistlich Bio-Gide® Perio is intended for the following uses: - 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; - filling of bone defects after root resection, cystectomy, removal of retained teeth; - guided bone regeneration in dehiscence defects, and - guided tissue regeneration procedures in periodontal defects. Geistlich Bio-Gide® Shape is indicated for: - 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. - filling of bone defects after root resection, cystectomy, removal of retained teeth; and - guided bone regeneration in dehiscence defects. Geistlich Combi-Kit Collagen: Geistlich Bio-Gide® is intended for the following uses: - 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; - filling of bone defects after root resection, cystectomy, removal of retained teeth; - guided bone regeneration in dehiscence defects; and - guided tissue regeneration procedures in periodontal defects. Geistlich Bio-Oss Collagen® is intended for the following uses: - augmentation or reconstructive treatment of the alveolar ridge; - filling of periodontal defects; - filling of defects after root resection, apicoectomy, and cystectomy; - filling of extraction sockets to enhance preservation of the alveolar ridge; - elevation of the maxillary sinus floor; - filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR): and - filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR). Geistlich Perio-System Combi-Pack: Geistlich Bio-Gide® Perio is intended for the following uses: - 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; - filling of bone defects after root resection, cystectomy, removal of retained teeth; - guided bone regeneration in dehiscence defects; and - guided tissue regeneration procedures in periodontal defects. Geistlich Bio-Oss Collagen® is intended for the following uses: - augmentation or reconstructive treatment of the alveolar ridge; - filling of periodontal defects; - filling of defects after root resection, apicoectomy, and cystectomy; - filling of extraction sockets to enhance preservation of the alveolar ridge; - elevation of the maxillary sinus floor; - filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and - filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation. Geistlich Bio-Gide® Shape is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Shape membrane has a pre-shaped form with a maximum width and height of 14 mm x 24 mm, respectively. Geistlich Bio-Gide® Compressed is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Compressed membrane is available in two different sizes, 13 x 25 mm and 20 x 30 mm. Geistlich Bio-Gide® Perio is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. Pre-formed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio. Geistlich Combi-Kit Collagen is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide®. The two devices are packaged in double blisters in one package and then sterilized by gamma irradiation. Geistlich Bio-Oss Collagen® is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation. Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® bilayer membrane to be provided in the Geistlich Combi-Kit Collagen convenience kit is 16 mm x 22 mm. Geistlich Perio-System Combi-Pack is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide® Perio. Geistlich Bio-Oss Collagen® (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation. Geistlich Bio-Gide® Perio (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® Perio bilayer membrane to be provided in the Geistlich Perio-System Combi-Pack convenience kit and as individual units is 16 mm x 22 mm. Preformed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect, and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.

The Nexo-Gide™ Bilayer Collagen Membrane is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

The Geistlich Nexo-Gide™ device, manufactured by Geistlich Pharma AG, is a resorbable collagen membrane of porcine origin, consisting of a compact smooth structure and of a porous structure that serves as an interface between the tendon and the surrounding tissues. Nexo-Gide™ Bilayer Collagen Membrane will be used as a tendon protector sheet that provides a nonconstricting, protective encasement for injured tendon, in the same manner as other tendon cover products like the predicate device TenoGlide (K053655, Integra Life Science). The Nexo-Gide membrane is made of collagen type I and III without further cross-linking or chemical additives and is sterilized by gamma irradiation. The available sizes are 20x30mm, 30x40mm and 40x50 mm.