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3D Systems Secures Class IIa EU MDR Certification for NextDent® Jetted Denture Solution, Enabling Full European Commercial Launch Two Months Ahead of Schedule

3D Systems has secured Class IIa certification under the European Union Medical Device Regulation (MDR 2017/745) for its NextDent Jetted Denture Solution, which includes the NextDent Jet Base and NextDent Jet Teeth materials along with the NextDent 300 MultiJet 3D printer. The regulatory approval enables the company to immediately begin commercial sales of the complete denture manufacturing solution across all EU markets, arriving two months earlier than originally projected. The certification represents a significant regulatory milestone for 3D Systems' dental manufacturing technology, as the EU MDR framework requires rigorous clinical evaluation and quality management system compliance for medical devices. The NextDent Jetted Denture Solution utilizes MultiJet printing technology to produce dental prosthetics, offering an alternative to traditional denture manufacturing processes through additive manufacturing techniques.

Why It Matters

This certification opens a major European market for 3D Systems' dental manufacturing technology and demonstrates the growing acceptance of additive manufacturing in regulated medical device markets. The early regulatory approval suggests strong technical documentation and quality systems, potentially accelerating adoption of 3D printing technologies in dental laboratories and clinics across Europe.

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