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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.

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.

Xenograft Bovine Bone Particulate is intended for use in dental surgery. The products may be used in surgical procedures such as: * Augmentation or reconstructive treatment of alveolar ridge * Filling of periodontal defects * Filling of defects after root resection, apicocectomy, and cystectomy * Filling of extraction sockets to enhance preservation of the alveolar ridge * Elevation of maxillary sinus floor * Filling of defects in conjunction with products intended for Guided Bone Regeneration (GBR) * Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)

The Xenograft Bovine Bone Particulate is a porous bone mineral matrix that is used in periodontal, oral, and maxillofacial surgery. It has a trabecular architecture, interconnecting macro and micro pores and consistency which allows formation and ingrowth of new bone. The particulate is available in clinically relevant sizes. The anorganic bone composition meets all requirements found in ASTM 1581-08: Standard Specification for Composition of Anorganic Bone for Surgical Implants. The device is packaged, and electron beam irradiated to meet all requirements and is non-pyrogenic. Using standard dental techniques, the dentist will loosely pack the xenograft particulate granules into the osseous defect using sterile instruments.

THE Graft Collagen is recommended for: - Filling of extraction sockets to enhance preservation of the alveolar ridge.

THE Graft Collagen, composed of porcine derived bone mineral matrix from cancellous bone and Type I Collagen from porcine tendon. The bone mineral matrix is similar to physical and chemical aspects of the mineralized matrix of human bone. Hydrated collagen components have viscosity that facilitates for blending of the bone mineral matrix. With this characterization, it can be trimmed and/or molded to the various shapes of defects. THE Graft Collagen is sterilized using gamma irradiation and recommended for the patient who needs filling of bone defects and bone augmentation. THE Graft Collagen is available in various sizes. Block (Height x Length x Width) 3 x 5 x 7 mm, 5 x 5 x 5 mm, 5 x 5x 10 mm, 7 x 7x 7 mm THE Graft Collagen contains 85% The Graft Bone Substitute (K173188) granules and 15% porcine collagen in a block form. The Graft Bone Substitute (K173188) is a porous bone mineral matrix available in cancellous granules made of porcine bone. Granules serve as a scaffold for new bone, and collagen holds the granules not to break away from the implanted site and facilitates handling.

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.

S1 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, apicocectomy, and cystectomy - · Filling of extraction sockets to enhance preservation of the alveolar ridge - · Elevation of the maxillary sinus floor · Filling of periodontal defects in conjuncts 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).

S1 is intended for filling and augmentation of bony voids and gaps in maxillofacial surgery, implantology, and periodontology according to the intended use of the product. S1 is serving as a matrix consisting of interconnected macro- and micropores. The material is porous and has inner surface area. S1 is a mixture of Hydroxyapatite (HAp) and hydroxypropyl methylcellulose (HPMC). Hydroxyapatite (HAp) is made from bovine cancellous bone and is mineralized hydroxyapatite. The bone particle size is 0.2 ~ 1.0mm for the powder type and 1.0 ~ 2.0 mm for the chip type. S1 is packaged in vials and it is supplied sterile by gamma irradiation and is for single use only.

InterOss® Collagen is indicated for filling of extraction sockets to enhance preservation of the alveolar ridge. InterOss Collagen is recommended for: Filling of extraction sockets to enhance preservation of the alveolar ridge Filling of periodontal defects in extraction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)

InterOss Collagen is a combination of InterOss®, an anorganic hydroxyapatite bone substitute, and collagen fibers for use in periodontal, oral and maxillofacial surgery. This product is a composite of 90% InterOss® (granules of size 0.25-1mm) and 10% porcine collagen fibers. InterOss®, which is already a cleared device by the FDA (K151209), is a hydroxyapatite material derived from Australian bovine bone. The osteoconductive mineral structure is produced from bone through a multi-step purification process. Following placement in bony voids or gaps InterOss® acts as an osteoconductive scaffold for the ingrowth of adjacent viable bone. InterOss® gradually resorbs and is replaced with bone during the healing process. The collagen component facilitates the adaptation of Inter Osse to the allowing easier handling. The product is non-pyrogenic, single use only, and terminally sterilized via gamma-irradiation. The product is available in the following shapes and sizes: | Type | Weight<br>(mg) | Dimension<br>(mm) | Ref# | |-------|----------------|-------------------|----------| | Block | 50 | 6 x 6 x 3 | IOC-50 | | Block | 100 | 6 x 6 x 6 | IOC-100 | | Block | 250 | 7 x 9 x 8 | IOC-250 | | Block | 350 | 8 x 10 x 9 | IOC-350 | | Block | 500 | 10 x 12 x 10 | IOC-500 | | Plug | 150 | 6 x 10 | IOC-P150 | | Plug | 250 | 8 x 10 | IOC-P250 | | Plug | 400 | 11 x 9 | IOC-P400 | | Plug | 450 | 10 x 12 | IOC-P450 |

Wishbone HA is intended for the following uses: · Filling of infrabony periodontal defects; · Filling of periodontal defects in conjunction with products intended for guided tissue regeneration and guided bone regeneration: · Filling of defects after root resection, apicectomy and cystectomy; - · Filling of extraction sockets to enhance preservation of the alveolar ridge; - · Augmentation or reconstructive treatment of the alveolar ridge; - · Elevation of the maxillary sinus floor; · Filling of peri-implant defects in conjunction with products intended for guided bone regeneration.

Wishbone HA is a xenograft biomaterial composed of deproteinized hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw. Wishbone HA is supplied as a mix of cancellous and cortical particles size 0.25 to 1.0 mm) in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation. The device is intended to be used in medical procedures, by a qualified physician (academically trained dentists, periodontists and oral surgeons).

Porcine Mineral Collagen Composite is intended to be used for bone grafting in periodontal, oral and maxillofacial surgeries. Porcine Mineral Collagen Composite is indicated for: - Augmentation or reconstructive treatment of 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 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).

Porcine Mineral Collagen Composite is an osteoconductive bone mineral with collagen composite for bone grafting in periodontal. oral and maxillofacial surgery. The device is composed of anorganic bone mineral granules derived from porcine cancellous bone and collagen from porcine Achilles tendon in compressed, formaldehyde-crosslinked, preformed sponge matrices designed to fit the size of the defect upon hydration. The product is supplied sterile, non-pvrogenic and for single use only. The product is available in the following shape and sizes: | Product Shape | Dimensions | |---------------|--------------------------------------------| | Plug | 10mm (5mm dry) x 17mm (diameter x length) | | Umbrella | 17mm (13mm dry) x 10mm (diameter x height) | | Umbrella | 22mm (17mm dry) x 12mm (diameter x height) |