FDA Clears Denture Material for 3-D Printers

Richard Gawel

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The NextDent Denture 3D+ biocompatible denture material from 3D Systems has received 510(k) clearance from the US Food and Drug Administration (FDA). The combination of this dental 3-D printing material, the NextDent 5100 dental 3-D printer, and intraoral scanning and dental software solutions yields more predictable results than analog techniques, 3D Systems says, enabling more efficient and cost-effective creation of dentures. 

Producing a denture using NextDent Denture 3D+ for the base and NextDent C&B MFH for the teeth on the NextDent 5100 results in a final denture that is 90% less expensive to product in 75% less time than dentures created using analog methods, 3D Systems says. The digital solution improves the patient experience as well, the company adds, providing a properly fitting device with fewer required office visits.

“With 3D Systems’ Digital Denture Workflow, dental laboratories and clinics are now able to produce dental devices at dramatically increased speed while reducing material waste and capital equipment expenditure as well as reliance upon milling centers,” said Rik Jacobs, vice president, general manager, dental, at 3D Systems. “FDA clearance of NextDent Denture 3D+ is the last piece that creates a trusted end-to-end workflow, giving prosthodontists a competitive advantage while improving the patient experience.”

NextDent Denture 3D+ material offers excellent mechanical properties in accordance with ISO Denture Base Standards, 3D Systems says, and can produce dentures rivaling conventional denture base materials. The company also says it offers the largest available color palette for a denture base material, enabling dental labs and clinics to deliver a final product that most closely matches a patient’s gums for a natural looking aesthetic.

The material joins 3D Systems’ portfolio of 30 unique NextDent resins, the largest number available from any dental 3-D printing material supplier, the company says. NextDent 3D printing materials are biocompatible and CE certified, with CE certification pending for NextDent Denture 3D+, in accordance with Medical Device Directive 93/42/EEC, listed at the FDA, and registered in other countries.

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