Stratasys Secures First FDA Clearance for TrueDent Dental Resin

Stratasys TrueDent: Revolutionizing Digital Dentistry with FDA-Cleared Multicolor 3D Printing

Stratasys, a global leader in additive manufacturing solutions, has significantly expanded its portfolio of dental materials with the introduction of TrueDent. This innovative, clear, and highly realistic dental resin marks a pivotal moment for the company as its first product to receive FDA clearance. Engineered for exclusive use with the Stratasys J5 DentaJet 3D printer and the powerful GrabCAD Print software platform, TrueDent is set to transform the production of various dental prosthetics. From full dentures to temporary crowns and bridges, this groundbreaking material offers dental laboratories an unprecedented opportunity for the batch production of monolithic, multicolor appliances, all consolidated on a single build tray with diverse parts.

The FDA clearance for TrueDent is a testament to its safety, efficacy, and readiness for clinical application. This crucial regulatory approval provides dental professionals with the assurance that TrueDent meets rigorous standards for medical devices, paving the way for its widespread adoption in dental labs committed to delivering high-quality, patient-specific solutions. The ability to print multiple shades and translucent areas within a single prosthetic, without manual assembly or painting, represents a significant leap forward in achieving lifelike aesthetics and streamlined workflows.

Beyond its aesthetic capabilities and integrated workflow, TrueDent boasts impressive mechanical properties that are essential for durable and reliable dental restorations. The resin demonstrates an ultimate flexural strength of ≥85 MPa, considerably exceeding the industry’s necessary minimum of ≥65 MPa. This superior strength indicates the material’s excellent resistance to bending and fracturing under typical oral forces, ensuring longevity for patients. In terms of flexural modulus, which measures the material’s ability to resist deformation under tension, TrueDent achieves a value of ≥2300 MPa, comfortably surpassing the legal minimum of ≥2000 MPa. This robust modulus ensures that dental appliances maintain their shape and integrity over time.

Furthermore, the TrueDent resin exhibits remarkable performance in terms of its sorption and solubility. Its sorption value, a combined measure of absorption and adsorption, is ≤ 32 μg/mm³. This low value is critical for dental materials, as it minimizes the uptake of oral fluids, which can otherwise lead to material degradation, discoloration, and potential hygienic issues. Finally, the solubility of the material is ≤1.1 μg/mm³, significantly below the legal limit of 1.6 μg/mm³. Low solubility ensures that the material does not leach harmful substances into the oral environment, further enhancing patient safety and the long-term stability of the dental restoration. These exceptional technical specifications underscore TrueDent’s suitability for producing high-quality, long-lasting, and biologically compatible dental devices.

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The TrueDent resin used for an upper jaw model

Strategic Vision: Stratasys’ Commitment to Digital Dentistry

“This new solution will be transformative for the dental industry, and we believe it will help our customers significantly reduce the time and cost of producing dentures and temporaries,” stated Ronen Lebi, Vice President of Dental at Stratasys. His remarks highlight the company’s ambition to drive innovation that directly addresses the pain points of dental labs and clinics. “Stratasys continues to push the boundaries of digital dentistry leveraging our portfolio of advanced 3D printing technologies, including hardware, resins, and software to deliver disruptive solutions that make a difference.”

Stratasys’ long-standing expertise in 3D printing, combined with its strategic focus on the healthcare sector, positions TrueDent as more than just a new material—it’s a comprehensive solution. By integrating cutting-edge hardware like the J5 DentaJet, sophisticated software like GrabCAD Print, and now the highly advanced TrueDent resin, Stratasys is enabling a truly seamless and efficient digital workflow. This integrated approach ensures optimal performance, ease of use, and consistent results, making high-quality dental prosthetics more accessible and affordable. The company’s vision is clearly centered on empowering dental professionals to adopt advanced manufacturing techniques that improve patient care and operational efficiency.

Transforming Dental Practices: The Broader Impact of 3D Printing

Beyond Traditional Methods: Speed, Precision, and Customization

3D printing is undeniably a cornerstone of the modern dental industry, offering professionals an unparalleled opportunity to produce highly customized products with significantly reduced lead times compared to conventional fabrication methods such as milling or traditional wax-up and casting. Where traditional methods often involve multiple manual steps, resulting in potential inconsistencies and lengthy turnaround times, 3D printing streamlines the process, from digital design to physical output. This not only accelerates production but also enhances precision, allowing for a perfect fit and superior patient comfort. For instance, the intricate geometries required for orthodontic appliances like braces or complex substructures for crowns can be printed with exceptional detail and accuracy, ensuring better therapeutic outcomes.

The shift to digital workflows, powered by advanced 3D printing resins like TrueDent, enables dental labs to transition from labor-intensive, analog processes to highly automated and repeatable digital manufacturing. This means less material waste, reduced manual errors, and the ability to produce multiple unique items simultaneously, optimizing batch production capabilities. A previous study, for example, highlighted the technical advantages of 3D printing in the production of crowns, demonstrating that 3D printed crowns exhibited a more faithful reproduction of the original digital model compared to milled alternatives. This level of precision translates directly into improved clinical outcomes and patient satisfaction, as restorations fit better and require fewer adjustments.

Diverse Applications in Modern Dentistry

The applications of 3D printing in dentistry are vast and continually expanding. Services range from the production of various orthodontic appliances, including clear aligners and retainers, to the fabrication of highly aesthetic dentures, crowns, and bridges. Furthermore, 3D printing is integral to creating accurate anatomical models for diagnostic purposes, surgical guides for implant procedures, and custom impression trays, significantly enhancing efficiency and accuracy across multiple dental specialties. The ability to produce patient-specific devices tailored to individual anatomy is a game-changer, fostering greater personalization in treatment plans.

The Evolving Landscape of Dental 3D Printing

Market Leaders and Innovation

While Stratasys has made a significant mark with TrueDent, the dental 3D printing market is a vibrant ecosystem featuring several key players pushing the boundaries of innovation. Companies like Formlabs, for instance, are prominent, offering solutions such as their Form 3B+ (an upgrade from the Form 3B), which cater to a wide range of dental applications, including models, surgical guides, and various prosthetics. These companies contribute to a competitive environment that fosters continuous advancements in material science, printer technology, and software integration, ultimately benefiting dental professionals and patients worldwide.

The demand for more efficient, precise, and aesthetically pleasing dental solutions continues to drive the growth of the dental 3D printing market. TrueDent, with its FDA clearance and unique ability to produce monolithic multicolor dental appliances, addresses a critical need for enhanced realism and simplified workflows in the production of temporary and permanent restorations. This innovation not only streamlines the manufacturing process but also elevates the quality and natural appearance of dental prosthetics, setting a new benchmark for digital dentistry.

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Dental devices such as braces can be made using 3D printing. (Photo credit: Dentistry Today)

The introduction of Stratasys TrueDent marks a significant milestone in the journey towards fully digital dental labs. Its combination of FDA clearance, advanced material properties, and multicolor printing capabilities, all within a seamlessly integrated ecosystem, promises to deliver unprecedented levels of efficiency, cost reduction, and aesthetic quality. As dental technology continues to evolve, solutions like TrueDent will be instrumental in shaping the future of patient care, making customized, high-performance dental prosthetics more accessible than ever before.

Would Stratasys’ TrueDent dental resin be a valuable addition to your lab? We invite you to share your thoughts in a comment below or join the conversation on our LinkedIn, Facebook, and Twitter pages! Don’t miss out on the latest 3D printing news—sign up for our free weekly Newsletter here, delivered straight to your inbox. You can also explore all our insightful videos on our YouTube channel.

*Cover photo credits: Stratasys