Dentsply Sirona and Dreve are advancing clinical evaluation of the FDA-cleared Primeprint Direct Aligner resin and will soon begin gathering in vivo evidence to assess its fit within the Primeprint and SureSmile digital orthodontic workflows.
Dentsply Sirona, the world’s largest diversified manufacturer of dental products and technologies, and Dreve, a long-standing leader in orthodontic materials and thermoforming technology, today announced progress on the evaluation of Primeprint Direct Aligner resin, a Dreve material that has received FDA clearance and is specifically tied to Dentsply Sirona’s Primeprint 3D printing system.
From Preclinical Promise to Clinical Evaluation
While not yet commercially available, preclinical evaluations conducted in collaboration with the University of Ulm have indicated promising material characteristics of Primeprint Direct Aligner resin.
“The material shows excellent recovery characteristics. We are currently not aware of any thermoforming material that shows comparable properties,” said Dr. Med. Dent. Fayez Elkholy, Senior Physician who participated in the University of Ulm study.
Next Steps
Building on these initial findings from the University of Ulm, the two companies are now advancing with a series of in vitro and in vivo study designs. These efforts are intended to further validate the early results and support the continued development of the technology. Future development activities will be guided by the outcomes of these studies and the resulting evidence.
“Direct-print aligners represent an exciting area of innovation in digital orthodontics,” said Mark Bezjak, Group Vice President, Americas at Dentsply Sirona. “With FDA clearance in place for Primeprint Direct Aligner resin, our focus has shifted to collecting clinical data that will inform whether, how, and when this material could be integrated within the Primeprint and SureSmile ecosystems.”
“Guided by a customer-first mindset, we deliver flexible orthodontic solutions that help clinicians meet the unique needs of every patient. As we advance digital orthodontics, we’re excited to partner with Dreve to explore how direct-print technology could strengthen the SureSmile ecosystem,” added Jill Uhryniak, Group Vice President, Orthodontics at Dentsply Sirona.
“At Dreve, advancing material science for clinical impact is core to our mission,” said Dr. med. dent. Volker Dreve. “The preclinical evaluations for Primeprint Direct Aligner resin are encouraging. We’re now working with Dentsply Sirona to gather the clinical evidence needed to understand the material’s real-world performance and potential value for clinicians and patients.”
About Dentsply Sirona
Dentsply Sirona is the world’s largest diversified manufacturer of professional dental products and technologies, with over a century of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering, including dental and oral health products as well as other consumable medical devices, under a strong portfolio of world-class brands. Dentsply Sirona’s innovative products provide high-quality, effective, and connected solutions to advance patient care and deliver better and safer dental treatment. Dentsply Sirona is headquartered in Charlotte, North Carolina. The company’s shares are listed in the United States on Nasdaq under the symbol XRAY. Visit www.dentsplysirona.com for more information about Dentsply Sirona and its products.
About Dreve
Dreve Dentamid is a family-owned, MDR-certified manufacturer of high-quality dental and laboratory products based in the U.S. and Germany. Founded in 1949, the company develops, produces, and distributes dental materials, laboratory systems, and digital manufacturing solutions worldwide. Its portfolio includes silicones for clinical and laboratory use, resin systems, thermoforming materials, and durable laboratory equipment for dentists and dental technicians. Dreve combines proven material technologies with modern digital workflows such as CAD/CAM and 3D printing and is recognized as a pioneer in 3D-printing materials. Visit www.dreve.com for more information about Dreve.
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