INTRODUCTION Oral health is one of the key indicators of well- being, overall health, and quality of life. Teeth simply play a significant role in the health system. However, oral diseases still affect 3.6 billion people world-wide. 1 This document will focus on how the Elos Accurate ® validated portfolio, a high quality prosthetic alternative to major implant systems, has been developed and tested in order to obtain its FDA clearance. As a beaming white smile comes at a cost and as most people with tooth decay and tooth loss have no health insurance, the need to reduce costs is felt especially by the restoring doctor, dental labs, etc. In that context, speed and choice of implant systems are key. Via our open digital workflow, you obtain the flexibility to work with various implant systems and their platforms without compromising quality. ELOS ACCURATE ® — ORIGINAL ELOS MEDTECH QUALITY Elos Accurate ® Hybrid Base™ and Elos Accurate ® Customized Abutments have received FDA 510(k) clearance for the U.S. dental implant market Elos Medtech’s open digital workflow and several of the solutions in the portfolio have obtained the FDA clearance for the US market. The entire portfolio has, however, already been successfully deployed in Europe for several years. It offers compatibility with almost all the major, global implant systems and their platforms and covers several clinical indications. The product portfolio contains: • Elos Accurate ® Customized Abutments • Elos Accurate ® Analog for Printed Models • Elos Accurate ® Model Analog • Elos Accurate ® Hybrid Base™ Non-Engaging • Elos Accurate ® Hybrid Base™ Engaging • Elos Accurate ® Scan Body This white paper documents that Elos Accurate products are safe to use and aims to give you the confidence to use them instead of solutions from major implant companies. If you want to work with original parts, work with original Elos Accurate . 1 WHO “Oral Health” 2021, https://www.who.int/health-topics/oral-health#tab=tab_1 2
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