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Text: James Woodcock
Dental AM is becoming a regulatory battleground, and the stakes are high. Europe’s Medical Device Regulation (MDR) sets a demanding bar for devices used in the mouth long-term, and achieving Class IIa certification, which is required for crowns, bridges and long-term removables, is the difference between selling or not.
3D Systems’ NextDent platform includes the NextDent 300 MultiJet printer, along with its NextDent Jet Base and NextDent Jet Teeth materials. All passed EU MDR Class IIa certification, with commercial availability in Europe now – two months ahead of schedule. The system is based on a monolithic multi-material jetting workflow, enabling dental labs to go from digital file to finished, patient-fitted monolithic denture in a single print run, without secondary curing.
Stratasys reached a similar milestone with its TrueDent resin in March, also achieving CE Class IIa certification in Europe. Two of the sector’s biggest names clearing the same regulatory hurdle within weeks of each other suggests that European dental labs are about to face a step-change in the quality and range of certified 3D printed restorative options available to them. For practitioners and their patients choice is always welcome news.
Further information:
3DSystems.com
AM Directory/3D Systems
Stratasys.com
AM Directory/Stratasys
