3D Systems announced that its NextDent Denture 3D+ biocompatible denture material has won FDA 510(k) clearance.
The Rock Hill, S.C.-based company said yesterday that the combination of dental 3D-printing material, intra-oral scanning and dental software solutions that make up the NextDent Denture 3D+ are designed to offer more precise, predictable results through analog techniques.
The NextDent Denture 3D+includes a large color palette for natural-looking aesthetic and the company said the material is capable of producing dentures that rival conventional denture base materials.
3D Systems said producing a denture using the NextDent Denture 3D+ with NextDent C&B MFH for teeth on the NextDent 5100 results in a final denture that is 90% less expensive to produce and in 75% less time than dentures created using standard analog methods. CE Mark approval for the material in Europe is still pending, the company said.
“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,” 3D Systems dental VP & GM Rik Jacobs said in a news release. “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.”
