3D Systems Receives FDA Clearance for First-to-Market Multi-material, Monolithic Jetted Denture Solution
3D Systems (NYSE:DDD) has received FDA 510(k) clearance for its innovative multi-material, monolithic jetted denture solution. This first-to-market offering combines NextDent® Jet Denture Teeth and NextDent® Jet Denture Base materials with 3D Systems' jetting technology, software, and services. The solution enables the production of durable, long-wear, and aesthetically pleasing dentures in a single print session.
Glidewell, a major dental device producer, is implementing this solution into its production workflow. The FDA clearance represents a significant milestone in 3D Systems' strategic initiative to expand its digital dentistry solution portfolio. This new denture product family is expected to tap into a market estimated to exceed $2 billion by 2028, significantly expanding the company's addressable dental market.
3D Systems (NYSE:DDD) ha ricevuto l'autorizzazione 510(k) della FDA per la sua innovativa soluzione dentale monolitica multi-materiale a getto. Questa offerta pionieristica combina i materiali NextDent® Jet Denture Teeth e NextDent® Jet Denture Base con la tecnologia di getto, il software e i servizi di 3D Systems. La soluzione consente la produzione di denture durevoli, a lunga durata e esteticamente piacevoli in un'unica sessione di stampa.
Glidewell, un importante produttore di dispositivi dentali, sta implementando questa soluzione nel proprio flusso di lavoro di produzione. L'autorizzazione della FDA rappresenta una tappa significativa nell'iniziativa strategica di 3D Systems per espandere il proprio portafoglio di soluzioni per l'odontoiatria digitale. Questa nuova famiglia di prodotti per dentiere dovrebbe attingere a un mercato stimato di oltre $2 miliardi entro il 2028, espandendo significativamente il mercato dentale indirizzabile dell'azienda.
3D Systems (NYSE:DDD) ha recibido la autorización 510(k) de la FDA para su innovadora solución de prótesis dentales monolíticas de múltiples materiales. Esta oferta pionera combina los materiales NextDent® Jet Denture Teeth y NextDent® Jet Denture Base con la tecnología de chorro, el software y los servicios de 3D Systems. La solución permite la producción de dentaduras duraderas, de larga duración y estéticamente agradables en una única sesión de impresión.
Glidewell, un importante productor de dispositivos dentales, está implementando esta solución en su flujo de trabajo de producción. La aprobación de la FDA representa un hito significativo en la iniciativa estratégica de 3D Systems para expandir su cartera de soluciones de odontología digital. Se espera que esta nueva familia de productos de dentaduras acceda a un mercado estimado en más de $2 mil millones para 2028, expandiendo significativamente el mercado dental direccionable de la empresa.
3D Systems (NYSE:DDD)는 혁신적인 다중 재료 모놀리식 재적 싯치 솔루션에 대해 FDA 510(k) 허가를 받았습니다. 시장에 처음으로 출시된 이 제품은 3D Systems의 제트 기술, 소프트웨어 및 서비스를 결합한 NextDent® Jet Denture Teeth 및 NextDent® Jet Denture Base 재료를 혼합합니다. 이 솔루션은 내구성이 뛰어나고, 오래 착용할 수 있으며, 미적으로 만족스러운 의치를 단일 인쇄 세션에서 생산할 수 있게 해줍니다.
대형 치과 기기 제조업체 Glidewell는 이 솔루션을 생산 워크플로에 적용하고 있습니다. FDA의 허가는 3D Systems의 디지털 치과 솔루션 포트폴리오를 확장하기 위한 전략 이니셔티브의 중요한 이정표를 나타냅니다. 새로운 의치 제품군은 2028년까지 20억 달러를 초과할 것으로 예상되는 시장에 진입할 것으로 보이며, 회사의 치과 시장 접근 가능성을 크게 확장할 것입니다.
3D Systems (NYSE:DDD) a reçu l'homologation 510(k) de la FDA pour sa solution prothétique monolithique à matériaux multiples innovante. Cette offre pionnière combine les matériaux NextDent® Jet Denture Teeth et NextDent® Jet Denture Base avec la technologie de jet, le logiciel et les services de 3D Systems. La solution permet la production de denture durables, à long terme et esthétiquement agréables en une seule session d'impression.
Glidewell, un grand producteur de dispositifs dentaires, intègre cette solution dans son flux de production. L'homologation de la FDA représente un jalon significatif dans l'initiative stratégique de 3D Systems visant à élargir son portefeuille de solutions de dentisterie numérique. Cette nouvelle gamme de produits de denture devrait accéder à un marché estimé à plus de 2 milliards de dollars d'ici 2028, élargissant ainsi considérablement le marché dentaire adressable de l'entreprise.
3D Systems (NYSE:DDD) hat die FDA 510(k) Zulassung für seine innovative multi-material, monolithische Jet-Zahnprothetik-Lösung erhalten. Dieses marktführende Angebot kombiniert NextDent® Jet Denture Teeth und NextDent® Jet Denture Base Materialien mit der Jet-Technologie, Software und Dienstleistungen von 3D Systems. Die Lösung ermöglicht die Herstellung von haltbaren, langanhaltenden und ästhetisch ansprechenden Zahnprothesen in einer einzigen Drucksitzung.
Glidewell, ein großer Hersteller von Zahnmedizinprodukten, setzt diese Lösung in seinen Produktionsablauf um. Die FDA-Zulassung stellt einen wichtigen Meilenstein in der strategischen Initiative von 3D Systems dar, die digitalen Zahnmedizinlösungen zu erweitern. Es wird erwartet, dass diese neue Produktfamilie von Zahnprothesen einen Markt ansprechen wird, der voraussichtlich bis 2028 über 2 Milliarden US-Dollar betragen wird, was den adressierbaren zahnmedizinischen Markt des Unternehmens erheblich erweitert.
- FDA 510(k) clearance received for multi-material, monolithic jetted denture solution
- First-to-market offering combining unique materials and 3D Systems' technology
- Partnership with Glidewell, one of the world's largest dental laboratories
- Expansion of addressable dental market, with denture demand estimated to exceed $2 billion by 2028
- Solution enables more efficient denture production for dental laboratories
- None.
Insights
This FDA clearance for 3D Systems' multi-material, monolithic jetted denture solution marks a significant advancement in dental prosthetics. The unique combination of NextDent® Jet Denture Teeth and NextDent® Jet Denture Base materials allows for the production of durable, aesthetically pleasing dentures in a single piece. This innovation addresses key challenges in traditional denture manufacturing, potentially improving patient comfort and satisfaction.
The ability to produce dentures with true multi-material properties in a single print session is a game-changer. It could lead to reduced production times, lower costs and improved consistency in denture quality. For patients, this could mean fewer dental visits and a more personalized fit. However, long-term clinical studies will be important to validate the durability and patient acceptance of these 3D-printed dentures compared to traditional methods.
3D Systems' FDA clearance for their jetted denture solution opens up a substantial market opportunity. With the global 3D Printed Dentures market projected to reach
Investors should note the potential for increased recurring revenue from materials sales, as labs adopt this technology. The solution's efficiency could drive higher margins for 3D Systems and its customers. However, the impact on the company's financials may take time to materialize as adoption rates in the conservative dental industry can be slow. Monitoring key metrics like material sales growth and new customer acquisitions in upcoming quarters will be important to gauge the success of this product launch.
3D Systems' jetted denture solution addresses a growing market need for efficient, high-quality dental prosthetics. The global trend towards digital dentistry aligns perfectly with this innovation. Key advantages include:
- Streamlined production process
- Reduced material waste
- Lower capital investment for dental labs
These benefits could accelerate adoption, particularly among larger labs seeking to improve efficiency. However, potential barriers include the initial cost of implementation and the learning curve for dental technicians. The partnership with Glidewell is strategically important, as it provides a high-profile case study that could influence other labs. Market penetration will likely depend on demonstrating consistent quality and cost savings over time, as well as patient satisfaction with the final product.
- Unique multi-material, single-piece dentures offer unparalleled combination of distinctive break resistance and outstanding aesthetics for enhanced patient experience
- Solution being implemented by Glidewell, one of the world’s largest dental laboratories
- FDA clearance represents another important milestone in Company’s strategic initiative to expand its market-leading digital dentistry solution portfolio addressing alignment, protection, repair, replacement of teeth
- New denture product family significantly expands company’s addressable dental market, with denture demand estimated to exceed
$2 billion by 2028
ROCK HILL, S.C., Sept. 17, 2024 (GLOBE NEWSWIRE) -- Today, 3D Systems (NYSE:DDD) announced the Food and Drug Administration (FDA) has provided 510(k) clearance for its multi-material, monolithic (one-piece) jetted denture solution. This first-to-market offering comprising two uniquely developed materials — NextDent® Jet Denture Teeth and NextDent® Jet Denture Base — as well as 3D Systems’ jetting technology, software and services, enables the production of durable, long-wear, aesthetically beautiful dentures. As a result of implementing the Company’s FDA-cleared jetted denture solution, dental laboratories can more efficiently deliver dentures, resulting in an enhanced patient experience.
Glidewell, one of the world’s largest producers of restorative dental devices, through its partnership with 3D Systems, received a preview of this solution and is now in the process of implementing it into its production workflow. “We take great pride in pioneering the use of new technologies to continually enhance our products and services,” said Stephenie Goddard, CEO, Glidewell. “We’ve worked with 3D Systems for many years, and using their digital dentistry solutions has helped us achieve tremendous success for our patients. As the first dental lab to have access to 3D Systems’ new multi-material, monolithic jetted denture workflow, we are looking forward to implementing a significantly better denture solution for our customers and their patients.”
“With the FDA clearance of our jetted denture solution, 3D Systems continues to expand our market-leading digital dentistry solution portfolio,” said Neil McCaffrey, vice president & general manager, dental, 3D Systems. “Replacement of teeth is a key pillar of our dental strategy, which is directly supported by this latest innovation. Our jetted denture solution reflects our commitment to the dental laboratory by offering a complete system that enhances automation and profitability within a traditionally labor-intensive workflow. This solution integrates innovations in hardware, software, materials, and process expertise, delivering in a single print session a one-piece denture with hard, wear-resistant, aesthetically beautiful teeth, in combination with tough, durable gingiva properties. Unlike other systems, our printer can produce a denture with true multi-material properties—not just color. With the growing use of digital imaging and personalized treatment planning in dental clinics worldwide, digitizing denture fabrication sets a new standard for creating robust, precise dental prosthetics that patients can truly see and feel. It's a win-win-win for laboratories, dentists, and patients.”
3D printing continues to play a significant role in the production of prosthodontics and its use is accelerating, driven by the benefits it delivers for both manufacturers and patients. According to 360 Market Updates, the global 3D Printed Dentures market size was estimated to be more than
For more information on 3D Systems’ jetted denture solution, please visit the Company’s website.
Forward-Looking Statements
Certain statements made in this release that are not statements of historical or current facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to be materially different from historical results or from any future results or projections expressed or implied by such forward-looking statements. In many cases, forward-looking statements can be identified by terms such as "believes," "belief," "expects," "may," "will," "estimates," "intends," "anticipates" or "plans" or the negative of these terms or other comparable terminology. Forward-looking statements are based upon management’s beliefs, assumptions, and current expectations and may include comments as to the company’s beliefs and expectations as to future events and trends affecting its business and are necessarily subject to uncertainties, many of which are outside the control of the company. The factors described under the headings "Forward-Looking Statements" and "Risk Factors" in the company’s periodic filings with the Securities and Exchange Commission, as well as other factors, could cause actual results to differ materially from those reflected or predicted in forward-looking statements. Although management believes that the expectations reflected in the forward-looking statements are reasonable, forward-looking statements are not, and should not be relied upon as a guarantee of future performance or results, nor will they necessarily prove to be accurate indications of the times at which such performance or results will be achieved. The forward-looking statements included are made only as of the date of the statement. 3D Systems undertakes no obligation to update or revise any forward-looking statements made by management or on its behalf, whether as a result of future developments, subsequent events or circumstances or otherwise, except as required by law.
About 3D Systems
More than 35 years ago, 3D Systems brought the innovation of 3D printing to the manufacturing industry. Today, as the leading additive manufacturing solutions partner, we bring innovation, performance, and reliability to every interaction — empowering our customers to create products and business models never before possible. Thanks to our unique offering of hardware, software, materials, and services, each application-specific solution is powered by the expertise of our application engineers who collaborate with customers to transform how they deliver their products and services. 3D Systems’ solutions address a variety of advanced applications in healthcare and industrial markets such as medical and dental, aerospace & defense, automotive, and durable goods. More information on the company is available at https://www.3dsystems.com.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/fdc3f56e-aae2-4ae0-8908-21d185db789e
| Investor Contact: | investor.relations@3dsystems.com |
| Media Contact: | press@3dsystems.com |
1 360 Market Updates, “Global 3D Printed Dentures Market Research Report 2022 (Status and Outlook)”, June 2022.
FAQ
What FDA clearance did 3D Systems (DDD) receive for its dental solution?
How does 3D Systems' (DDD) new denture solution benefit dental laboratories?
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Which major dental laboratory is implementing 3D Systems' (DDD) new denture solution?
