Graphy Completes Final EU MDR Review for Five Dental Materials

The materials are three products in the TeraHarz Clear series — TC-85DAC, TA-28 and TR-07 — and two in the TeraHarz series, TC-80DC and BR-23. The EU MDR, Regulation (EU) 2017/745, imposes stricter requirements than the previous Medical Devices Directive, including rules covering clinical evidence, technical documentation, risk management, quality systems and post-market surveillance.

Graphy said the review covered product safety and performance as well as quality management and the ability to address safety throughout a product’s lifecycle. The company described completion of the review as a step toward expanding European supply of its dental printing materials, including materials used for shape-memory aligners.

The company plans to grow local manufacturing and distribution partnerships in Europe, where it has been expanding its network in markets including Germany. Its partnership with Smilers, the clear aligner brand of France-based Biotech Dental, is intended to explore product validation and commercialization using Graphy’s materials and manufacturing technologies. Under the proposed approach, local partners would make and supply dental products using those technologies, while Graphy supplies materials.

Graphy also cited U.S. FDA 510(k) clearance and registration with Brazil’s National Health Surveillance Agency (ANVISA) as part of its regulatory progress in other markets. Chairman Un seob Sim said the company plans to expand European partnerships once certificates are issued and turn its materials technology into orders and revenue. Graphy is listed on KOSDAQ under ticker 318060.