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Ceracell® Ortho Foam is intended to fill bony voids or gaps of the skeletal system (posterolateral spine). These osseous defects may be surgically created or from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the posterolateral spine Ceracell® Ortho Foam is to be mixed with autograft bone. The device resorbs and is replaced with bone during the healing process.

Ceracell® Ortho Foam is a porous composite material consisting of resorbable ß-tricalcium phosphate ceramic granules (85% by weight of the final device) in a porcine collagen scaffold (Type I and Type III, 15% by weight of the final device). Ceracell® Ortho Foam is provided as Ceracell® Ortho Flexible Foam Strip and Ceracell® Ortho Moldable Foam. Ceracell® Ortho Flexible Foam Strip is provided in various sizes from 2.5 cc to 25 cc. Ceracelle Ortho Moldable Foam is provided in various sizes from 1.2 cc to 25 cc.

Cerasorb Ortho Foam is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Cerasorb Ortho Foam resorbs and is replaced with bone during the healing process.

Cerasorb Ortho Foam is a highly porous composite material for bone augmentation and regeneration applications, consisting of porcine collagen and a resorbable ceramic. Through the use of pure phase ß-tricalcium phosphate with a regular interconnected porous structure, a degradation of the biomaterial is achieved simultaneously to natural bone regeneration. The pure phase B-tricalcium phosphate is made according to ASTM F 1088-04a. The ß-tricalcium phosphate component of Cerasorb Ortho Foam is a mixture of Cerasorb M Ortho and Cerasorb Ortho, which received previous 510(k) clearances (K040216 and K014156, respectively). The device has been tested to meet pyrogen limit specifications. Cerasorb Ortho Foam is available in five different sizes and two versions (mouldable foam and flexible foam strip) and serves to fill bone defects in the entire skeletal system.

Osseolive® DENTAL is indicated for applications in oral and maxillofacial surgery and dentistry, including filling and/or reconstruction of multi-walled (artificial or degenerative) bone defects, e.g.: - Defects after the extirpation of bone cysts . - Augmentation of an atrophied alveolar ridge ● - Sinus lift or sinus floor elevation (subantral augmentation) ● - Filing of alveolar defects after tooth extraction for preservation of the alveolar ridge - Filling of extraction defects to create an implant bed . - Filling of two- or multi-walled bone pockets as well as the bi- and trifurcation defects . - . Defects after operative removal of retained teeth or corrective osteotomies

Osseolive® DENTAL is a synthetic absorbable radiopaque silicated calcium-alkali-phosphate ceramic for filling, bridging and reconstructing bone defects and for bone fusion in dental and maxillofacial applications. Osseolive® DENTAL has an open-cellular porosity of about 80% and is available as polygonal granyles of various grain sizes. It is resorbed by the body over a period of months and simultaneously substituted by local autologous bone. As a synthetic, bioactive ceramic material Osseolive® DENTAL has excellent intra- and extra-osseous tissue compatibility and is neither locally nor systemically toxic. Osseolive® DENTAL is a calcium-sodium phosphate with an open sintered structure. Osseolive® DENTAL morsels are highly porous, available in different grain size fractions between 150 and 2000 um. The high porosity allows blood components and body fluids to penetrate the material rapidly and unhindered. The chemical composition is a modification of tricalcium phosphate, where one calcium atom is replaced by one potassium atom and one sodium atom, resulting in increased solubility. Doping this glass ceramic with 4% sodium-magnesium-silicate on interstitial positions ensures the maximum mechanical stability. Osseolive® DENTAL has a resorption time of 3 to 12 months. Osseolive® DENTAL morsels are packaged for sale in glass vials.

Ceracell® DENTAL is indicated for: - Augmentation or reconstructive treatment of the alveolar ridge - Filling of infrabony periodontal defects . - Filling of defects after root resection, apicoectomy, and cystectomy - Filing 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 perio-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)

Ceracell® DENTAL is a synthetic absorbable radiopaque bio-ceramic for dental and maxillofacial bone regeneration, using pure phase beta-tricalcium phosphate with an open-cell sintered structure of biocompatible, bioactive organic and osteoconductive material. Ceracell® DENTAL polygonal 'morsels' have a porosimately 80% and are available in a grain sizes from 150 - 2,000 µm, with the intended use of filling dental and maxillofacial bone defects. This level of porosity allows rapid ingrowth of the bone, and blood components are able to permeate the material, leading to osseous integration and vascularisation. The material is doped with 4% sodium-magnesium-silicate to provide mechanical stability. Ceracell® DENTAL morsels are available in a range of morsel sizes and quantities. The final product is packed in glass vials, fitted with brombuty rubber stoppers, then subjected to a gamma radiation sterilization process before being packed in outer cartons. Resorption time varies with technique from 4 to 12 months.

Osbone® DENTAL is intended for the filling and reconstruction of multi-walled bone defects, e.g .: - · Defects after removal of bone cysts - · Augmentation of the atrophied alveolar ridge - · Sinus lift and sinus floor elevation (subantral augmentation) - · Filling of alveolar defects following tooth extraction for alveolar ridge preservation - · Filling of extraction defects to create an implant bed - · Filling of two- or multi-walled infrabony pockets, and bi- and trifurcation defects - · Support function for a membrane in controlled tissue regeneration (CTR) - · Defects after surgical removal of retained teeth or corrective osteotomies - · Other multi-walled bone defects of the alveolar processes.

Osbone® DENTAL is an open-cellular, synthetic bioceramic for bone regeneration. It is comprised of a pure phase hydroxyapatite with an open sintering structure resulting in a biocompatible, bioactive and osteoconductive biomaterial. Osbone® DENTAL morsels are open-cellular highly porous morsels, ranging from 150-8000 um for filling bone defects in dental procedures. While Osbone® DENTAL can be manufactured with a granule size of up to 8000 um, curasan will only market granule sizes of 0.25-2.0 mm, which is within the size range of the predicate devices. The high porosity helps to accelerate ingrowth of bone.

Cerasorb® MIX is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structures. It is indicated for filling of bone defects, caused by surgery, trauma or degenerative process. Cerasorb® MIX granules are intended to be gently packed into the bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine, and pelvis). Cerasorb® MIX is not indicated for use in load-bearing applications. It does not possess sufficient mechanical strength, therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization. Following placement in the bony voids or gaps, the Beta-tricalcium phosphate granules are gradually resorbed and replaced with new bone.

The Cerasorb® MIX Device is a mixture of two legally marketed bone void filler devices, the Cerasorb Ortho granules subject of K014156 and Cerasorb M Ortho granules subject of K040216. The bone replacement and bone regeneration material Cerasorb MIX consists of ≥99% pure phase beta-tricalcium phosphate (beta-TCP). The Cerasorb® and Cerasorb® M mixture includes granule sizes of 500-1000 um and 1000-2000 um. The mixing ratio is 1cc to 1cc of Cerasorb® and Cerasorb® M granules. The material should not be packed in dry form; it should be mixed with autologous blood (blood from the void or venous blood). The implanted material must be in direct contact with the bleeding vital bone.

The REVOIS® Implant System is an implant system recommended for: Surgical placement in the edentulous or partially edentulous jaw bone (upper or lower jaw bone) to create support for prosthetic devices such as single artificial teeth, fixed or removable bridges or dentures. The titanium implant can be applied either in a one-stage surgical procedure with immediate loading when good primary stability is achieved and with appropriate occlusal loading, or in a two-stage surgical procedure (after osseointegration of the implant). Angled abutments on small diameter implants (3.8 mm) of the REVOIS® Implant System are intended for the anterior region of the mouth and not intended for the posterior region of the mouth due to limited strength of the implant.

The REVOIS® Implant System is a self-contained, modular dental implant system for placement into the jaw bone (upper or lower jaw bone) to support prosthetic devices for dental restoration. The system is designed for one-stage or two-stage surgical procedures. The REVOIS® Implant System is composed of a titanium, screw type implant, preassembled with a multifunctional precision abutment and a transfer tool that snaps onto the abutment (Snap-on-tool). The implant is also available with a transfer tool only. A cover screw is contained in the top of the snap-on or transfer tool. The system offers implants in various diameters and lengths (3.8; 4.3; 5.0 mm diameter; 9; 11; 13; 15 mm lengths). The REVOIS® Implant System is provided with a number of corresponding tools and surgical instruments, as well as a variety of prosthetic components. For ease of identification the implants and corresponding tools are color coded according to diameter. The main components of the implant system are made of Grade IV or Grade V Titanium (implant, abutment) or plastic (snap-on tool, transfer tool). The materials comply with the ASTM standards ASTM F067 (implant), ASTM F0136-2a (abutment) and ASTM F2026 (Snap-on tool, Transfer tool). The implant surface is blasted with zirconium and then acid-etched for roughness. The REVOIS® titanium implant (pre-assembled with the multifunctional precision abutment and snap-on-tool or with the transfer tool only) is supplied in double sterile packages (sterile inner plastic vial in a sterile glass vial, which is sealed in a blister) and is for single use only. Tools and other re-usable instruments must be sterilized prior to use.

Cerasorb® M DENTAL is recommended for: - 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). Cerasorb® DENTAL is recommended for: - 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). Cerasorb® Perio is recommended for: - Filling and/or reconstruction of non-infected periodontal bone defects in conjunction with other products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR). - Filling of infrabony periodontal defects - Filling of single-or multi-wall bone pockets. - Filling of bifurcations and trifurcations

Cerasorb® DENTAL, Cerasorb® M DENTAL and Cerasorb® Perio are a sterile, synthetic, ceramic matrix in either granular form (Cerasorb DENTAL), polygonal shaped morsels (Cerasorb M DENTAL) or polygonal broken granulate (Cerasorb Perio). This material consists of pure-phase Beta-Tricalcium Phosphate with a phase purity of > 97% and complies with the ASTM F 1088-04. The devices, when applied to a bony defect, create a matrix of large, smoothly interconnected pores providing an osteoconductive scaffold (Cerasorb DENTAL approx. 65 vol% [total porosity], Cerasorb M DENTAL approx. 65 vol% [total porosity] and Cerasorb Perio approx. 25 vol%). The different designs are managed and controlled by a validated manufacturing process which guarantees batch to batch conformity and reproducibility. Due to their synthetic nature the devices are free of any biological contaminants and are neither locally nor systemically toxic. In contact with vital bone the Cerasorb granules, morsels or granulate is resorbed and gradually replaced by new bone. Cerasorb DENTAL, Cerasorb M DENTAL and Cerasorb Perio are provided in double sterile packaging (sterilized by gamma irradiation) and are for single-use only.

Cerasorb® M ORTHO (polygonal broken morsels) is intended for use as a bone void filler in voids or gaps (resulting from surgery, trauma or degenerative processes) in the skeletal system (e.g. extremities, spine, pelvis) that are not intrinsic to the stability of the bony structure. Following placement in the bony void or gap, the ß-TCP ceramic material is gradually resorbed and replaced with bone. The placement of Cerasorb® M ORTHO should not be in dry form, the material should be mixed with autologous blood.

The device modification is a change in the shape resp. size of the bone void filler. The predicate device Cerasorb® ORTHO, a synthetic, porous, resorbable and osteoconductive bone void filler, was developed in granular form (spherical granules) of different diameter (500-1000um, 1000-2000um) to be filled in the bone void(s). The material consists of pure phase Beta-Tricalcium Phosphate of interconnecting porosity. This submission is intended to address a modification in the shape of the bone void filler. The bone void filler is now additionally presented as polygonal shaped morsels of different sizes ranging from 50 8000m. The pure phase Beta-Tricalcium Phosphate material is of interconnecting microporosity and additionally contains defined interconnecting meso-, and macropores (50 - 500 um).

Cerasorb" ORTHO (granular or block forms) is intended for use as a bone void filler in voids or gaps (resulting from surgery, trauma or degenerative processes) in the skeletal system (extremities, spinc, pelvis) that arc not intrinsic to the stability of the bony structure. Following placement in the bony vold or gap, the B-TCP ceramic material is gradually resorbed and replaced with bonc. The placement of Cerasorb ORTHO should not be in dry form, the material should be mixed with autologous blood.

The predicate device Cerasorb™ ORTHO, a synthetic, porous, resorbable and osteoconductive bone void filler, was developed in granular form (spherical granules) of different diameter (500-1000um, 1000-2000um) to be filled in the bone void(s). The material consists of pure phase Beta-Tricalcium Phosphate of interconnecting porosity. This submission is intended to address a modification in the shape of the bone void filler. The bone void filler is now additionally presented as block forms of different geometry (for example wadge, cylinder, cube, parallelepiped) and in different sizes up to 30cc. The basic pure phase Beta-Tricalcium Phosphate material is also of interconnecting microporosity. Straight through macropores of different size (500-2000um) are mechanically introduced by drilling.