Graphy Completes Final CE-MDR Review for Five Key Dental 3D Printing Materials and Awaits Certificate Issuance

Five TeraHarz materials pass final review under the EU's strengthened Medical Device Regulation. Graphy plans to expand European manufacturing and distribution partnerships, including its collaboration with Smilers, the clear aligner brand of France-based Biotech Dental, while strengthening its global materials supply business.

SEOUL, South Korea, Nov. 10, 2026 — Graphy Inc. (KOSDAQ: 318060), the first company to commercialize direct 3D-printed Shape Memory Aligners (SMA™), announced that it 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 company is now awaiting issuance of the certificates.

The five materials comprise three products from the TeraHarz Clear series (TC-85DAC, TA-28 and TR-07) and two from the TeraHarz series (TC-80DC and BR-23). The conformity assessment and final review procedures have been completed, and the certification process will conclude once the certificates are issued.

Meeting the EU's Strengthened Medical Device Requirements

The EU Medical Device Regulation (Regulation (EU) 2017/745) sets stricter requirements than the previous Medical Devices Directive (MDD), particularly for clinical evidence, technical documentation, risk management, quality management systems and post-market surveillance.

The assessment covers not only device safety and performance but also manufacturers' quality management systems and their ability to manage safety throughout the product lifecycle. The scope and complexity of the review can vary depending on the product's characteristics and the applicable conformity assessment procedure.

Completion of the final review demonstrates that Graphy's proprietary materials technology and quality management capabilities have passed the assessment process under the EU's strengthened medical device requirements.

Completing the review for five core materials strengthens the foundation for expanding Graphy's supply of dental 3D printing materials in Europe, including materials used to produce shape memory aligners.

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 combination of proprietary materials technology and manufacturing processes supports Graphy's efforts to differentiate its products in the global digital orthodontics market.

Expanding European Manufacturing and Distribution Partnerships

Completion of the final review is also expected to support closer cooperation with European partners. Graphy has been expanding its local distribution network and partnerships in key European markets, including Germany.

Once the certificates are issued, Graphy plans to accelerate the supply of its core materials and pursue new commercial opportunities in Europe.

Beyond direct materials exports, the company is pursuing a business model that combines local manufacturing and distribution partnerships with recurring materials supply.

A recent example is Graphy's strategic partnership with Smilers, the clear aligner brand of France-based Biotech Dental. The collaboration aims to explore product validation and commercialization opportunities using Graphy's proprietary materials and manufacturing technologies.

Under this business model, local partners would manufacture and supply dental products using Graphy's materials and manufacturing solutions, under either their own brands or the Graphy brand.

By drawing on partners' existing production capabilities and distribution networks, Graphy aims to expand its market reach while reducing the need for direct investment in local manufacturing facilities. Ongoing materials supply is intended to generate recurring revenue.

Building on Global Regulatory Progress

Graphy has strengthened its international business foundation by securing regulatory clearances and registrations in major markets, including U.S. FDA 510(k) clearance and registration with Brazil's National Health Surveillance Agency (ANVISA).

Building on its presence in North America, Asia and Latin America, Graphy plans to use this progress toward CE-MDR certification to strengthen materials supply and local business partnerships in Europe.

"Completing the final CE-MDR review is significant because five of our core dental 3D printing materials have passed the rigorous assessment process under the EU's strengthened medical device requirements," said Un seob Sim, Chairman of Graphy.

"Once the certificates are issued, we will expand our local manufacturing and distribution partnerships in Europe and translate our proprietary materials technology into tangible orders and revenue."

Media Contacts

Graphy Inc.
Ace Gasan ForHu, 6F, 225 Gasan Digital 1-ro, Geumcheon-gu, Seoul
[email protected] | [email protected] | [email protected]
https://www.itgraphy.com 

SOURCE Graphy Inc.