Yxoss CBR Customized Bone Regeneration CAD/CAM Technologies for Tailor-Made Bone Regeneration

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1 distributed by Yxoss CBR Customized Bone Regeneration CAD/CAM Technologies for Tailor-Made Bone Regeneration

2 Quality and Precision are our strengths 1. Horizontal and vertical bone defect Custom Bone Regeneration 1. 3D-model of the bone defect 2. Definition of the desired final volume for the regeneration provides solutions for custom bone regeneration. Patient-specific titanium mesh scaffolds are manufactured utilizing modern CAD / CAM technology and delivered tailored to precisely fit the defect. Simply send CT- or DVT data, assess the design and augment according to the prefabricated custom-shaped titanium mesh. - Technology (patented) 2. Model and virtual regenerated bone 3. Yxoss CBR for custommade bone augmentation (CBR - Customized Bone Regeneration) Individually made Yxoss CBR mesh scaffolds provide the augmentation site with previously unmet stability and form-fit for the planned augmentation volume. The Yxoss CBR mesh structure allows undisturbed bone healing, free from compressive loads and other physical influences. With the patented manufacturing process for the preparation of individual patient solutions, provides high quality individual products for custom bone regeneration. 3. 3D-model mesh scaffold in position 4. 3D-model: occlusal view 5. View of the crestal breaking point for easy removal In bone defect augmentation, the final bone structure is an important success criterion for satisfying high aesthetic expectations. In addition to the barrier function of Bio-Gide, the positional stability of the augmentation is of highest priority for regeneration. The high quality mesh scaffold (Yxoss CBR, made of pure titanium) generated through the digital work flow system control the shape of the bone augmentation and fit perfectly over the bone defect 1. Horizontal and vertical bone defect of the maxilla 3. Yxoss CBR - high quality mesh scaffold of pure titanium 2. 3D-Design 4. Accurate placement with perfect fit over the bone defect The - technology unites function and design for success custom-fit and tissue compatibility high stability during the healing phase predefined augmentation volume simple fixation and easy removal (Easy Removal Design ) reconstruction of original anatomical shape (e.g. Jugae alveolariae) easy use and significantly shortened operating time for regeneration of complex bone defects Images: Dr. Marcus Seiler MSc, Filderstadt 5. Mesh scaffold in situ filled with autogenous bone 6. Fixation with a mini-screw 2 3

3 Products Yxoss CBR - Tailor-made design Yxoss CBR - Easy Application Yxoss CBR has revolutionized oral bone augmentation by customizing the commonly used titanium meshes during production with digital workflow to fit the individual anatomy of each patient. Each titanium mesh is custom-made for a precision fit that accurately reflects the specific patient data provided. Time-consuming impressions, cutting, shaping and adapting are no longer necessary and sharp edges from cutting conventional meshes are entirely eliminated. The unique mesh structure enables superb load-bearing capacity in both compression and shear forces. DVT-presentation of the mesh scaffold in position The design shape and the tissue compatibility of pure titanium allow good nourishment for the regenerating bone. Filling of the mesh with bone and/or Bio-Oss The augmentation region remains undisturbed within the scaffold during the healing phase. The Yxoss CBR custom-made device is delivered double packaged in sterilization pouches. Sterilization is achieved before surgery simply by autoclaving the device in its inner package. The mesh structure is then filled with the preferred bone augmentation material and fitted to the defect. Fixation is performed with a selftapping titanium screw (recommended length: 5-8 mm, may vary depending on the situation; diameter 1.2 mm). The innovative design allows for variable placement of the fixation screws. Easy fixation with mini titanium screws in any position. Computation of Augmentation Volume On request, calculates the necessary augmentation volume for your case planning. As part of a design order, this service is free of charge. You obtain the data together with a 3-D design proposal made by our design center. The volume is given in cubic millimeters. This gives the advantage that exact planning for the amount of bone required is possible, or enough information is at hand to allow selection of the correct Bio-Oss package size Harvesting of autogenous bone Bio-Oss and bone chips Simple Removal with Easy Removal Design Our engineers design an area in the crestal region of each device to allow for atraumatic removal. This predefined breaking point allows easy removal with a raspatory, without necessitating a full-thickness flap. Separation with periosteal elevator after removal of the mini-screw Lifting the second side plate with a raspatory Both side plates can now be easily removed Completely regenerated ridge after removal of the mesh scaffold Images: Dr. Marcus Seiler MSc, Filderstadt 4 5

4 Case 1 59-year-old patient with a combined horizontal and vertical bone deficit in regions and In addition, difficult soft tissue situation. Surgeon: Dr. Marcus Seiler MSc, Filderstadt 1. Initial clinical situation 2. Significant horizontal deficit visible in DVT 15. DVT-control five months postoperative - transverse plane 16. DVT-control five months postoperative - sagittal plane 17. Clinical situation four weeks after soft-tissue healing 3. Sagittal view in DVT 4. Virtual 3D model to represent the bone deficit 5. Surgical approach with a split-flap technique 18. Presentation of regenerated alveolar ridge in region Inserted implants in region for subsequent single-tooth restorations 20. Clinical situation in region before re-entry 6. Exposure of the alveolar ridge after preparation of the split-flap 7. Yxoss CBR mesh scaffold with incorporated pre-determined breaking point 8. Retromolar bone harvesting with a hollow trephine drill 21. Crestal incision for removal of Yxoss CBR 22. Removal of the fixation screw 23. Separation at the breaking point with a periosteal elevator 9. Grinding of the bone cylinders in a bone mill 10. Mixture of Geistlich Bio-Oss and autogenous material (ratio 1:1) 11. Yxoss CBR loaded with autogenous bone and Geistlich Bio-Oss 24. Removed Yxoss CBR plates after separation at the breaking point 25. Regenerated alveolar ridge in region Insertion of 3 dental implants in region Yxoss CBR in situ with fixation screws 13. Wound closure with a collagen membrane (Geistlich Bio-Gide ) in place 14. Two-layered suture closure with Gore-Tex 27. Healed soft-tissue with gingiva formers in place 28. Postoperative OPG after implantation 29. Prosthetic restoration phase with impression posts (Final restoration not yet available at time of printing) 6 7

5 Case 2 Case 3 32-year-old patient with a pronounced horizontal and vertical bone deficit in regions 33 and 34 after removal of a central giant-cell granuloma. Surgeons: Dr. Dr. Keyvan Sagheb and Prof. Dr. Dr. Wilfried Wagner, University Medical Center Mainz 1. Significant horizontal and vertical bone deficit in regions 33 und DVT imaging of the defect area 49-year-old patient with a substantial vertical and horizontal bone defect in region after explantation of three alio loco inserted implants. Surgeon: Dr. Karl-Ludwig Ackermann, Filderstadt 1. Radiological initial situation before explantation 2. 3D model simulation of situation after several months of bone healing 3. Model simulation with Yxoss CBR 4. Surgical approach with a poncho flap 5. Try-in of Yxoss CBR 3. Virtual augmentation 4. Yxoss CBR inlay with predetermined breaking points 5. Ausgangssituation mit extrem ungünstiger vertikaler Komponente 6. Bone harvesting with the Safescraper method 7. Fixation with osteosynthesis screws 8. Situation after complete soft-tissue healing 6. Surgical approach with a poncho flap 7. Try-in of Yxoss CBR - planned bone volume can be seen 8. Autologous bone chips mixed with Geistlich Bio-Oss for filling 9. DVT six months later to examine the regeneration process 10. Re-entry showing the regenerated alveolar ridge 11. Yxoss CBR mesh and fixation screws after removal 9. Fixation of Yxoss CBR with miniscrews 10. Covering with a collagen membrane (Geistlich Bio-Gide ) 11. Two-layered wound closure 12. Insertion and positioning of the implants 13. Plastic wound closure with single sutures 14. Postoperative OPG after implantation 12. OPG after positioning the Yxoss CBR mesh scaffold 13. Wound healing 1 week post-op 14. Clinical situation five months postop 8 9

6 Case 4 68-year-old patient with a combined horizontal and vertical bone defect in regions and with a difficult soft-tissue situation. Surgeon: Dr. Marcus Seiler MSc, Filderstadt 1. Initial clinical situation with thin gingival biotype 2. Significant horizontal deficit both buccal and palatal 15. Exposed implants in region Clinical situation in region Horizontal and vertical bone deficit in region Virtual 3D model to represent the bony situs 4. Virtual augmentation in 3D model 5. Custom-fit Yxoss CBR model with predetermined breaking point 18. Sagittal view of DVT showing the alveolar ridge 19. Surgical approach through a crestal incision 20. Yxoss CBR with integrated breaking point 6. Clinical situation from occlusal view 7. Crestal surgical access with presentation of the alveolar ridge 8. Yxoss CBR before insertion 21. Try in of the custom-made Yxoss CBR 22. Filling of Yxoss CBR with autogenous material and Geistlich Bio-Oss 23. Fixation of Yxoss CBR - fill of the bone harvesting site with collagen 9. Retromolar removal of bone cylinders with a hollow trephine 10. Filled Yxoss CBR (autogenous material and Geistlich Bio-Oss ) 11. Fixed Yxoss CBR 24. Control DVT after five month shows good regeneration 25. Separation at the predetermined breaking point (Easy Removal Design ) 26. Regenerated alveolar ridge in region Five months after augmentation - with natural jaw contour 13. The control DVT after five months shows good regeneration 14. Inserted implants Wound closure 28. Insertion of two implants (positions 32 and 42) for subsequent bridge restoration 29. Soft-tissue situation after exposure of the implants 10 11

7 Case 5 Case 6 39-year-old patient with a substantial horizontal and vertical bone deficit in region after trauma. 56-year-old patient wished fixed dentures. Horizontal augmentation of After healing, implantation in positions 15, 13, 12, 22, 23 and. 25. Surgeons: Dr. Dr. Keyvan Sagheb and Prof. Dr. Dr. Wilfried Wagner, University Medical Center Mainz 1. Large horizontal and vertical bone defect in region Initial clinical situation Surgeon: Dr. Marcus Seiler MSc, Filderstadt 1. Horizontal deficit from many years of wearing mucosa-supported full dentures 2. Initial clinical situation - 3. Surgical approach through a crestal incision 4. Try-in of Yxoss CBR - buccal view 5. Try-in of Yxoss CBR - occlusal view 3.Presentation of the bony situs with a full-thickness flap 4 Yxoss CBR with several incorporated predetermined breaking points 5. Try-in of Yxoss CBR - planned bone volume can be seen 6. Filled Yxoss CBR 7. Yxoss CBR covered with PRF-A 8. Wound closure 6. Autologous bone chips after retromolar bone harvesting 7. Filled Yxoss CBR 8. Fixation of Yxoss CBR with four mini-screws 9. Postoperative OPG with Yxoss CBR in situ 10. Situation three weeks after augmentation 11. Control DVD to verify regeneration five months post-op 9. Saliva-proof plastic wound closure 10. DVT six months later 11. Separation at the predetermined break points (Easy Removal Design ) 12.Careful detachment of Yxoss CBR 13. Regenerated alveolar ridge after removal of Yxoss CBR 14. Insertion of 4 implants in positions 15,13,12 and Introduction of six implants in positions 15, 13, 12, 22, 23 and Exposed implants before definitive prosthodontic treatment 14. Definitive prosthetic restoration 12 13

8 Products How to Order 1. Start with : Registration and order Design, manufacturing and customer service Use the simple ordering process and data upload over our website. In your personal MyReOss account you will easily and at any time find all information on your cases and the respective design and production steps. 2. Fill out the order form: Information on the planned OP Or simply send us your CD-ROM with the DICOM data with CT or DVT images. We take care of setting up your personal MyReOss account and the first data upload.. 3. Odontogram: Choose augmentation area 6. Data Transfer: Easy and safe transmission of 3D-data (CT or DVT) Questions about the ordering process: Geistlich Biomaterials Tel Questions about treatment planning or your account: GmbH Talstrasse 23 D Filderstadt contact@reoss.eu From Germany: Tel Fax Order at a fixed price: Immediate offer, no hidden costs 5. Pay conveniently: By credit card or bank transfer 7. 3D display technology: Before the product is made, you receive a 3D design for evaluation and ordering 8. You keep an eye on everything: From order to delivery Through a patented process we produce a custom-made dimensionally stable mesh scaffold made of pure titaniumaccording to your specifications submitted by CT or DVT images for patient-specific bone regeneration (CBR = Customized Bone Regeneration). We also offer complete customer support through the product design process for your surgery. Our specialists know in great detail the practice internal processes, the surgical challenges and the biological limitations. Quality assurance Every step of the manufacturing processes of implants fulfils quality requirements according to EN/ISO Our products fulfill the defined requirements of the European Directive RL93/42 EEC, Annex VIII for custom-made medical devices in terms of product performance and patient safety

9 Yxoss CBR Easy ordering at 1 Request and Offer Enter patient data in the protected area MyReOss, upload to GmbH... -> You will immediately receive an offer for the design process and can place an order. 2 3D-Design to review - quick and easy online... click CT or DVT data, upload to GmbH start and place order. Within a few days you will receive the notification to assess the design on MyReOss.. 3 Assessment and order Assess the 3D-Design and order production of Yxoss CBR titanium mesh scaffold. Experienced clinicians are available for a consultation. The delivery arrives a few days after the production order is placed and you can implant your Yxoss CBR titanium mesh scaffold immediately after receipt and sterilization. GmbH Talstrasse 23 D Filderstadt contact@reoss.eu Kontakt Geistlich Geistlich Biomaterials Vertriebsgesellschaft mbh Schneidweg 5, Baden-Baden From Germany:: Tel Fax International: Tel Fax: Tel Fax emil.endress@geistlich.de

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