[Edaily Reporter NA EUN-KYUNG ] #Graphy Inc. has completed the conformity assessment for five types of dental 3D printing materials under the European Medical Device Regulation (CE-MDR) and is set to receive final certification. The company explained that this lays the groundwork for expanding the supply of dental materials—including shape-memory transparent aligners (SMA)—and establishing local partnerships in the European market.

Graphy Inc. announced on the 10th that it has completed all CE-MDR conformity assessment and final review procedures for five core dental 3D printing materials. Once the certification body finalizes the certificate issuance process, CE-MDR certification for these products will be complete.

The products that have passed the review include three items from the “TeraHarz Clear” line (TC-85DAC, TA-28, TR-07) and two items from the “TeraHarz” line (TC-80DC, BR-23). Graphy Inc. plans to expand its supply of dental 3D printing materials in Europe following the completion of this review.

The CE-MDR is the Medical Device Regulation implemented by the European Union (EU) to replace the previous Medical Devices Directive (MDD). It is characterized by stricter requirements regarding product safety and performance, as well as clinical evidence, technical documentation, risk management, quality management systems, and post-market safety management.

In particular, it assesses whether manufacturers have established systems to continuously manage the safety and performance of their products even after launch. Consequently, depending on the risk class and certification pathway of a medical device, the documentation and procedures required for the review may increase compared to previous standards.

Graphy Inc. emphasizes the significance of having completed the final review not for a single product, but for its five core materials. Once certificates of conformity are issued for each product, the company expects to accelerate the supply of materials through its local European distribution network and secure new clients.

Graphy Inc.’s core business, SMA, is an orthodontic appliance that combines shape-memory materials with 3D printing technology. While conventional clear aligners are manufactured using a thermoforming process that presses plastic sheets onto tooth models, Graphy Inc. directly prints the aligners based on digital design data.

A key feature of this process is that it is designed to apply orthodontic force to the teeth by leveraging the properties of shape-memory materials. Based on this material technology and manufacturing method, Graphy Inc. is expanding its business in the global clear aligner market.

In Europe, the company is also pursuing production and distribution partnerships with local firms. A recent collaboration with “Smilers,” the clear aligner brand of French biotech firm Biotech Dental, is a prime example. Under this model, local partners use Graphy Inc.’s materials and manufacturing solutions to produce and supply products under their own brand or the Graphy brand.

This business model offers the advantage of reducing the investment burden associated with establishing direct overseas production facilities while leveraging the local partner’s production facilities and sales networks. Graphy Inc. expects that as product output increases, recurring revenue from material supply will also grow.

Previously, Graphy Inc. laid the groundwork for entering overseas markets by obtaining U.S. Food and Drug Administration (FDA) 510(k) clearance and registration with Brazil’s National Health Surveillance Agency (ANVISA). Once the CE-MDR certification process is complete, the company plans to expand its business into Europe, following its presence in North America, the Americas, and Asia.

Shim Woon-seop, Chairman of Graphy Inc., stated, “The completion of this final CE-MDR review is highly significant, as it means our five core dental 3D printing materials have passed the rigorous evaluation process under Europe’s strengthened medical device regulations.” He added, “With the issuance of the final certificate, we will expand our local production and distribution partnerships in Europe and translate our proprietary material technology into tangible orders and sales results.”