FDA Clears 3D Systems' NextDent® Denture 3D+

Posted on November 7, 2019

3D Systems has announced that its new biocompatible denture material, NextDent® Denture 3D+, has received 510(k) clearance from the US Food and Drug Administration (FDA). The combination of this new dental 3D printing material, NextDent 5100 dental 3D printer, and industry-leading intraoral scanning and dental software solutions yields an end-to-end digital dentistry solution. As a result, customers can expect more precise, predictable results than through analog techniques, enabling more efficient, cost-effective creation of dentures for patients.

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 produce in 75% less time than dentures created using analog methods. The digital solution improves the patient experience as well, 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, 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 possesses excellent mechanical properties (in accordance with ISO Denture Base Standards) and is capable of producing dentures rivaling conventional denture base materials. 3D Systems offers the largest available color palette for a denture base material, which enables dental labs and clinics to deliver a final product that most closely matches a patient’s gums for a natural-looking esthetic. This material joins the company’s portfolio of 30 unique NextDent resins – the largest number available from any dental 3D printing material supplier. NextDent 3D printing materials for medical devices are biocompatible and CE certified (CE certification is pending for NextDent Denture 3D+) in accordance with Medical Device Directive 93/42/EEC, listed at the FDA, and registered in various other countries. The complete NextDent portfolio–for both medical and non-medical devices–is suitable for a wide range of applications.

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