Dental Asia January/February 2024

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PRODUCT HIGHLIGHTS Vivos Therapeutics receives first FDA 510(k) clearance for oral device treatment of severe obstructive sleep apnea Vivos Therapeutics, a medical device and technology company specialising in the development and of treatments for sleep related breathing disorders, announced that it has been granted 510(k) clearance from the US Food and Drug Administration (FDA) for treating severe obstructive sleep apnea (OSA) in adults using the Vivos’ removable CARE (Complete Airway Repositioning and/or Expansion) oral appliances. Vivos’ CARE appliances include the DNA oral appliance, the mRNA oral appliance and the mmRNA oral appliance. With the clearance, Vivos is reportedly the first company to have approved and bring to market an alternative treatment to continuous positive airway pressure (CPAP) or surgical neurostimulation implants for patients with severe OSA. This latest clearance comes 11 months after the FDA granted Vivos 510(k) clearance for the DNA oral appliance to treat mild-tomoderate OSA, and represents the first time the FDA has granted an oral appliance a clearance to treat moderate and severe OSA in adults, 18-years of age and older along with positive airway pressure (PAP) and/or myofunctional therapy, as needed. “Before this, severe OSA patients’ only realistic treatment options were CPAP, neurostimulation implants or other The Vivos DNA appliance (left) and mRNA appliance (right) (Image: Vivos Therapeutics) invasive surgeries. Today, they have what we believe is a far more desirable option that is very affordable and does not require surgery or a lifetime of nightly use and intervention,” said chairman and CEO of Vivos, Kirk Huntsman. According to the company, the statistically significant data submitted to the FDA from 73 severe OSA patients showed that 80% of patients experienced an improvement of at least one classification or at least a 50% improvement in the Apnea Hypopnea Index (AHI), and 97% of patients improved or stayed the same. The average treatment time was 9.7 months. Treatment results with severe sleep apnea patients were better than with mild and moderate patients. All pre- and posttreatment testing was conducted with no device in the mouth. The company further added that unlike other oral appliances on the market, Vivos’ proprietary CARE appliances gradually reposition the hard and soft tissues that define the airway, thereby opening it up and optimising its function and flow. DA Myerson introduces Trusana 3D Premium Denture System, exclusively distributed by Zahn Dental Manufacturing digital dental materials company Myerson has announced the launch of the Trusana Premium Denture System. The system is comprised of Trusana Premium 3D Tooth Resin and the newly released Trusana Premium 3D Denture Base Resin and Trusana Bond Denture Adhesive. The three products work together to create a denture with optimal physical properties and aesthetics. Created by a team of scientists and clinicians from around the world, Trusana resins won a RadTech/UVA Emerging Technology award for additive manufacturing in 2020. wear-resistance. Trusana also mirrors the beauty and translucency of a natural smile. “We are thrilled to introduce the new Trusana Premium Denture System. We dedicated years of university-based research to create resins for 3D printing denture teeth with exceptional wear resistance and optimal esthetics and a denture base with high-impact strength. Independent clinical and in vitro multisite studies have shown our patented 3D resins deliver the requisite strength and toughness with minimal moisture absorption,” said president and CEO for Myerson, Jim Swartout. (Image: Myserson) and technology, and the ability to produce final digital dentures that maintain strength and the characteristics of a traditional denture. Together, the Trusana premium 3D resins result in a high-quality product for doctors while helping to save time, money, and materials. Trusana’s patented chemistry delivers an aesthetic, unfilled polymer with high flexural strength, fracture toughness, and The Trusana premium denture system is designed to provide dental labs what they are seeking in terms of innovative science Zahn Dental, the US dental lab business of Henry Schein, Inc, is the exclusive distributor of Trusana resins. DA 58 DENTAL ASIA JANUARY / FEBRUARY 2024
PRODUCT HIGHLIGHTS Carbon introduces three new resins to its platform Carbon has announced the release of three resins on its platform — Pac-Dent Rodin Sculpture, Desktop Health Flexcera Base, and Keystone KeyGuard. The launch is part of Carbon’s initiative (Image: Carbon, Desktop Health, Keystone and Pac-Dent) to facilitate innovation in the dental industry, empowering labs to diversify their production capabilities and explore new applications. → DISCOVER PERFECTION IN PROPHYLAXIS - THE NEW COMBI touch “With the introduction of these new resins, dental labs can look forward to improving their workflow efficiency and product offerings while providing customers with the latest in dental care advancements,” said co-founder and office of the CEO, Phillip DeSimone. “Each resin will unlock new opportunities for dental labs and further highlight Carbon’s unwavering resolve to drive dental industry innovation via advanced, best-in-class resins.” → ultra-gentle prophylaxis → ergonomic handling → made in Italy → 40 years experience Pac-Dent Rodin Sculpture Resin: Developed for modern dental restorations, the Pac-Dent Rodin Sculpture Resin introduces a new all-on-x solution for long-term provisionals on the Carbon platform for precision, aesthetics, and strength. This resin is the first in Carbon’s lineup that is FDA 510k-cleared for all-on-x temporary dental appliances, offering a nanohybrid ceramic formulation for lifelike permanent restorations. Additionally, it is reportedly the first permanent crown material to contain over 50% ceramic filler, meeting requirements for updated ADA insurance code reimbursements D2740, D2630, and D2644. Desktop Health Flexcera Base: Following the successful validation of Flexcera Smile Ultra+ restorative tooth resin, Flexcera Base joins Carbon’s portfolio as the latest innovation in denture base materials. This resin is designed for creating highimpact denture bases, combining optimal fracture resistance with good aesthetic quality. Both Flexcera Base and Flexcera Smile Ultra+ are FDA-cleared, ensuring that dental labs can confidently offer reliable permanent and temporary solutions to their customers. Keystone Industries KeyGuard: Keystone Industries brings to the Carbon platform the Keystone KeyGuard, a flexible resin for crafting high-quality, custom-fit mouthguards. This addition offers dental professionals the opportunity to design sports mouthguards digitally with custom variable wall thicknesses to provide comfort and protection to the end user. DA → www.mectron.com DENTAL ASIA JANUARY / FEBRUARY 2024 59
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Page 33 and 34: DENTAL PROFILE “We aim to not onl
Page 35 and 36: CLINICAL FEATURE The necessary reas
Page 37 and 38: CLINICAL FEATURE The harmful effect
Page 39 and 40: CLINICAL FEATURE Efficient layering
Page 41 and 42: CLINICAL FEATURE Same-day dentistry
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Page 47 and 48: USER REPORT All about the All-on-4
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Page 51 and 52: BEHIND THE SCENES Recognising such
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Page 65 and 66: EVENTS CAL NDAR 2024 JANUARY 13 - 1
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Dental Asia January/February 2024

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