The companies will gather clinical data for the FDA-cleared Primeprint Direct Aligner resin to assess its fit within the Primeprint and SureSmile workflows.
Dentsply Sirona and Dreve announced they are advancing to the clinical evaluation stage for the Primeprint Direct Aligner resin. The material, developed by Dreve for Dentsply Sirona’s Primeprint 3D printing system, has received FDA clearance but is not yet commercially available.
Preclinical Findings
Preclinical evaluations conducted in collaboration with the University of Ulm indicated promising material characteristics for the resin.
“The material shows excellent recovery characteristics. We are currently not aware of any thermoforming material that shows comparable properties,” says Dr Fayez Elkholy, senior physician who participated in the University of Ulm study, in a release.
Next Steps in Evaluation
Building on the initial findings, the companies are now proceeding with a series of in vitro and in vivo studies. These efforts are intended to further validate the early results and inform the continued development of the technology.
“Direct-print aligners represent an exciting area of innovation in digital orthodontics,” says Mark Bezjak, group vice president Americas at Dentsply Sirona, in a release. “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.”
“As we advance digital orthodontics, we’re excited to partner with Dreve to explore how direct-print technology could strengthen the SureSmile ecosystem,” says Jill Uhryniak, group vice president, orthodontics at Dentsply Sirona, in a release.
“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,” says Dr Volker Dreve, in a release.
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