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High Quality Implants Made by MONDEAL OMF / Oral Maxillo Facial

Introduction A facial surgical operation is not only about functional aspects like for instance speaking, chewing, breathing or swallowing. It is rather about the aesthetic and acceptance of the new face. The face represents our individual business card and therefore each of us becomes distinctive. The OMF (oral and maxillofacial surgery) includes the identification, the therapy, the prevention and the rehabilitation of diseased conditions of the face. These come mostely from injuries, fractures, tumor diseases or facial skeleton malformations involving changes in form of the jawbone connected with tooth displacement. A special focus is on the functional recovery and the aesthetic rehabilitation of the face. Indications: Trauma Jawbone-atrophy Tumors Facial paralysises Deformities Skeletal jawbone malpositions Tooth displacement 2

MONDEAL OMF / Oral Maxillo Facial MONDE face mandible pre-implant dental neuro tools 3

MONDE face MICRO 1200 The titanium implant system for highest standards in the field of osteosynthesis in the upper third of the skull. Color code: blue 1200 MONDE face 1700 MINI 1700 The titanium implant system with smaller plates and screws as perfect complement to the osteosynthesis in the upper two thirds of the skull. Color code: green 2000 MINI 2000 The titanium implant system specifically designed for the osteosynthesis of the oral and maxillofacial surgery and universally usable. Color code: red Areas of application Systems Naso-orbital area Infra-orbital area External wall of the maxillary sinus Frontal sinus Fixation of bone grafts Cranial area Midface Le Fort I, II, III Mandible Orthognathic surgery 4

MONDE mandible MPS MPS (Mandibular Polyvalent System) The Mandibular Polyvalent System provides a complete selection of plates and screws for both, trauma applications, as well as the reconstruction of the mandible. The modular concept makes it the system of choice for trauma and poly-trauma indications, as well as for the mandibular reconstruction with vascularized bone grafts in the tumor surgery. MONDE mandible FRACTURE BMR BMR (Bendable Mandibular Reconstruction System) The titanium mandibular reconstruction system is not only suitable for the use of both, primary and secondary bridging indications, but also for the anatomical position fixing or as internal fixation. FRACTURE System The fracture implant system ensures a solid fixation in many types of fractures of the mandible. The plates with options of compression allow a safe and easy stabilization of the jaw. New Concept New Design Proven Technology Modular System Clusters Proven MONDEAL systems for osteosynthesis and mandibular surgery united under a new name in an innovative modular principle. The many years of successful practicing of OMF- and Mandible-systems are reason for the further development and optimization of the systems with focus on functionality, modularity and efficiency. Depending on need and use, the components can be assembled individually by the enduser Logical color coding of the different systems Innovative and modular storage system 5

MONDE pre-implant MONDE pre-implant ARCS Alveolar Reconstruction System SIS Sinus Implant Stabilizer ARCS (Alveolar Reconstruction System) - Self-tapping and self-drilling screws - Microplates with 0.6 mm thickness - MICRO MESH for a solid covering of large bone defects - Titanium membranes for the covering of medium and small bone defects SIS (Sinus Implant Stabilizer) Depending on the implant system and the SIS implant diameter, the SIS-version Standard or the SIS-version Large is used. Thereby, the SIS is fixed between the implant and the healing screw. Additionally, the SIS implant composite can be fixed using the ARCS micro screws which fit into the small holes in the SIS. SWING LIFT SWING LIFT Thanks to the unique oscillation effect of the special tools, the SWING LIFT instruments for direct sinus lift increase the operating sensitivity and reduce the risk of perforation of the Schneiderian Membrane. MONDE pre-implant Systems for Pre- Implantology The atrophied alveolar crest causes problems in case of supply of enossal implants due to missing bone structure. This can be remedied by autologous bone grafts. A simple method to attach the bone grafts to the jaw is to fi x them using microscrews, either directly or in combination with titanium micromesh. 6

MONDE neuro MONDE neuro NEURO Flexible Plating System NEURO Cranio-Quick Cranio- Quick NEURO Flexible Plating System This user-friendly osteosynthesis system was developed in order to cover most areas of the cranium. High quality and flexible plates in combination with selfdrilling screws ensure a perfect fixation and at the same time a minimum consumption of material. NEURO Cranio-Quick The Cranio-Quick sets contain selected plates and screws for special cranial indications: Self-drilling screws Miniaturized plates Double sterile packaging Double sterile packaging Craniotomy Set with Double Y-Plate Craniotomy Set with 2-hole Plates 7

MONDE tools MONDE tools BBM Angled Screwdriver BBM (Bull Bone Mill) The handy and ergonomic bone mill BBM is used for the manual preparation of autologous bone grafts from cancellous/compact bone. Due to the very effective and easy-operating cutting cylinder available in 3 different sizes, an optimal result can be achieved even with small quantities of bone. Angled Screwdriver The Angled Screwdriver is the perfect instrument for the intraoral access. The drilling and the insertion of the screws are substantially simplified by the angled screwdriver. It can be used manually, as well as combined with a driving unit. Product information Detailed information about our products and systems can be found in our brochures. 8

Orthodontics MONDEFIT LOMAS MONDEFIT / LOMAS The MONDEFIT system was developed based on the LOMAS system. Due to the compatibility of both systems by using the same instruments, this combination covers many orthodontic indications with amazing results e.g. Mesialization / Distalization of molars). Orthodontics 3D- VESTIPLATE 3D-VESTIPLATE This system provides the OMF surgeon with special bone plates for the intraoral fixation in the mandible and maxilla. This provides the perfect solution to achieve increased stability of the anchorage and an ideal tensile direction. 3D- RINGSPLINT 3D-RINGSPLINT The 3D Adhesive Ringsplint has not only proven to be successful in the case of tooth dislocations of various sizes, but also in numerous other analog conditions. The 3D Adhesive Ringsplint is also applicable in cases of root fractures and for the splinting of teeth that have become loosened due to chronical apical development and further for the splinting of transplanted teeth. Orthodontics All our orthodontic products are distributed through: Am Gewerbering 7 78570 Mühlheim a. d. Donau/Germany Phone +49 7463 99307 60 Fax +49 7463 99307 66 info@arno-fritz.com www.arno-fritz.com Skeletal anchorage at its best! 9

MONDEAL Philosophy Customers Many of our customers rely on surgical and orthopedic systems, products and implants made by MONDEAL Medical Systems GmbH since years. The manufactured products are in great demand in many surgical and orthopedic applications of medical technology and have proven successfully. Advice Rely on our personal and experienced advice that enables a skillful implementation and realization of your ideas. We value on on-site customer support and direct contact to make sure you are in good hands. Take advantage of the flexible possibilities of our in-house construction, as well as the variable manufacturing and assembly methods. Flexibility The special internal structure of MONDEAL Medical Systems GmbH allows us to react to complex and individual requirements in order to fullfill these. By working together with selected partners, we are able to provide the surgical and orthopedic systems and implants at any time on schedule and in best quality without exception. Teamwork The close cooperation between the different business areas is only possible due to the individual strengths of each team member. Thanks to trainings and upgrade training courses, all staff members are skilled in their trade creating a solid foundation for advice and service. Teamwork and a good working environment are the basis for the implementation of the high standards of precision and quality set in all of our production processes. Only by being task-oriented, determined and with effective communication, the increasingly complex demands can be met. Because only together, goals can be achieved. Contact You would like to become acquainted with MONDEAL and our products? Please contact us: MONDEAL Medical Systems GmbH Am Gewerbering 7 78570 Mühlheim a. d. Donau/Germany Phone +49 7463 99307 0 Fax +49 7463 99307 33 mail@mondeal.de www.mondeal.de 10

MONDEAL Quality Highest demands on the quality of our products are a given as quality ensures reliability in use. Due to in-house development and in-house production facilities, we can manage to achieve the set standards on quality and reliability in every working step. High Quality Implants MONDEAL implant systems are notable for highest quality of the materials used for the manufacturing of the products, as well as the feature of having graceful shapes with optimized characteristics in case of application. All products go through strict controls. Thus, for instance all screws have to be verified on surface character and accuracy of fit several times before leaving the factory to meet our high quality requirements. Construction, manufacturing and distribution of the company MONDEAL Medical Systems GmbH are certified according to DIN EN ISO 13485. This quality assurance system conforms to the requirements of the Annex II to Medical Devices Directive 93/42/EEC. In addition, it also meets the regulatory requirements of various countries around the world. High Quality Implants Made by MONDEAL Made by MONDEAL At our location in Mühlheim a.d. Donau near Tuttlingen, all modern requirements relevant to the construction, the manufacturing and the assembly of our products are available. The development of each product is supported by our engineers using the latest CAD technology. This e.g. enables a detailed 3D view of the prototype already in the design phase. The resulting and well-engineered products are realized by using modern CNC manufacturing technology, as well as the proven water jet technology preventing damage to the surface. The production process is completed by our assembly departments and own prototype and tool construction - implemented by highly motivated and qualified staff. The in-house production and therefore the harmonization of blade, screws and plate allow a perfect interaction of all components. Benefi ts of titanium for implants In general, pure titanium (DIN EN ISO 5832-2/ASTM F67) is used for the manufacturing of bone plates while the titanium alloy Ti6Al4V (DIN EN ISO 5832-2/ASTM F136) is used for the manufacturing of bone screws. Worldwide, these materials are used for short and long-term implants in the osteosynthesis for decades. For the following reasons: Completely biocompatible Corrosion-resistant Non-toxic in the biological environment Failure-free imaging with X-rays, computed tomography (CT) and magnetic resonance imaging (MRI) 11

High Quality Implants Made by MONDEAL We reserve the right to make catalog and design changes arising from further developments and modifications. Pictures, product descriptions and texts are the property of MONDEAL Medical Systems GmbH. Further use and reproduction by Third Parties requires written consent from MONDEAL Medical Systems GmbH. All rights reserved! Note: Responsibility for the selection of the patient, for adequate training as well as the decision as to the choice and use of the implants, a post-operative removal or retention of implants is the sole decision of the surgeon. All brands and logos referred to in this brochure, registered by Third Parties, are subject without restriction to the legal provisions currently in force and to the rights of ownership of the respective registered owner. 2016 - MONDEAL Medical Systems GmbH Am Gewerbering 7 78570 Mühlheim a. d. Donau/Germany Phone +49 7463 99307 0 Fax +49 7463 99307 33 mail@mondeal.de 97-F100-E OMF 01/12-16