Graphy Completes Final EU MDR Review for Key Dental 3D Printing Materials

SEOUL, South Korea, Nov. 10, 2026 /CourierPR/ -- Graphy Inc., the first company to commercialize direct 3D-printed Shape Memory Aligners (SMA™), has completed the final conformity assessment review for five of its key dental 3D printing materials under the European Union's Medical Device Regulation (EU MDR). The materials, which include three from the TeraHarz Clear series (TC-85DAC, TA-28, and TR-07) and two from the TeraHarz series (TC-80DC and BR-23), have passed the rigorous assessment process. Graphy is now awaiting issuance of the certificates.

The EU MDR, which sets stricter requirements than the previous Medical Devices Directive, covers not only device safety and performance but also manufacturers' quality management systems and their ability to manage safety throughout the product lifecycle. This comprehensive review ensures that Graphy's proprietary materials technology and quality management capabilities meet the stringent standards set by the EU.

The completion of the final review for these core materials strengthens the foundation for expanding Graphy's supply of dental 3D printing materials in Europe. The company plans to accelerate the supply of its core materials and pursue new commercial opportunities in Europe once the certificates are issued. Graphy aims to expand its local manufacturing and distribution partnerships, including its collaboration with Smilers, the clear aligner brand of France-based Biotech Dental.

Graphy's Shape Memory Aligner (SMA™) combines direct 3D printing from digital design data with the properties of shape-memory materials. Unlike conventional thermoformed aligners, SMA is designed to use the material's shape-memory properties to deliver sustained orthodontic forces. This innovative approach supports Graphy's efforts to differentiate its products in the global digital orthodontics market.

In addition to its European expansion plans, Graphy has secured regulatory clearances and registrations in major markets, including U.S. FDA 510(k) clearance and registration with Brazil's National Health Surveillance Agency (ANVISA). These achievements build on Graphy's presence in North America, Asia, and Latin America, and position the company to strengthen its materials supply and local business partnerships in Europe.

Graphy Inc. (KOSDAQ: 318060) is a Seoul-based advanced materials company specializing in 3D printing materials and digital solutions for orthodontics and restorative dentistry. The company developed the direct 3D-printed Shape Memory Aligner (SMA™) using its proprietary shape-memory photopolymer technology.