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. 11, 2026 /PRNewswire/ -- 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."

About Graphy Inc.

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.

Graphy combines proprietary materials, direct 3D printing technology and global partnerships to serve dental professionals and industry partners worldwide. Following its acquisition of RAY, Graphy is expanding the group's capabilities in digital diagnostics, software, manufacturing and distribution to connect diagnosis, treatment planning, production and clinical care.

Media Contacts

Graphy Inc.
Ace Gasan ForHu, 6F, 225 Gasan Digital 1-ro, Geumcheon-gu, Seoul
ckyoon@itgraphy.com | digwack@itgraphy.com | jheonlee@itgraphy.com
https://www.itgraphy.com 

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

Responding to demand for improved indoor environments in large facilities, company strengthens collaborations built on its Icheon production base and overseas supply experience

SEOUL, South Korea, Nov. 11, 2026 /PRNewswire/ -- Window film manufacturer NEXFIL is broadening its business into architectural and commercial facilities, including hotels and restaurants. Building on collaborations with a major domestic hotel, an environmental and hygiene specialist, and a franchise restaurant chain, the company is expanding the number of sites where its architectural films are installed and responding to demand for better indoor environments in large facilities.

According to NEXFIL, its architectural films are being applied at a major domestic hotel, an environmental and hygiene specialist company, and a large franchise burger restaurant, among other sites. Building on the architectural product line it has operated alongside its automotive films, the company is pursuing collaborations tailored to the operating objectives of each facility.

The company cites prolonged heat waves and growing demand for indoor environment management as the background to these collaborations. NEXFIL believes that reducing indoor heat load from sunlight and maintaining a comfortable environment have become key challenges for large facilities. In response, it is extending the use of films that manage heat entering through windows to hotels, restaurants, and similar venues.

NEXFIL said it is collaborating with the hotel and the environmental and hygiene specialist to manage pest entry and create more comfortable indoor environments. At the large franchise burger restaurant, its film is also being used to improve the comfort of the space. Drawing on this field experience, the company plans to further expand collaborations in the hotel, food service, and environmental sectors.

The company's architectural film business is supported by its own research and production system. Founded in 2001, NEXFIL develops and manufactures window film at its corporate research institute and production facilities in Icheon, Gyeonggi Province. The company handles the entire process in-house, from base film processing and coating to sputtering and finished product manufacturing, and operates both architectural and automotive product lines.

Its core production technology is a multilayer sputtering process. By forming multiple metal layers on the film to reflect solar heat, the process serves as the main technological foundation of NEXFIL's architectural and automotive heat-rejection film businesses. The company also cites as a competitive strength its domestic production of wide-width sputtered film, which requires advanced process technology.

NEXFIL expanded its production capacity in 2025 by adding a wide-width sputtering line. Backed by its own manufacturing base, the company pursues domestic installations and overseas supply in parallel. According to NEXFIL, approximately 93% of its total output is exported to more than 60 countries worldwide.

Product performance is disclosed through metrics such as infrared rejection rate (IRR) and total solar energy rejection (TSER). NEXFIL presents clear visibility alongside heat rejection as a key product characteristic, and also cites its patents and high-efficiency energy equipment certification as part of its technological foundation.

As it grows, the company plans to continue pairing product supply with training for installation partners. Drawing on its experience producing in Korea and supplying multiple overseas markets, NEXFIL aims to widen the range of installation sites and expand market touchpoints through collaboration with installation partners. It also plans to pursue its premium multilayer sputtered film business in overseas markets, including the United States.

NEXFIL is also focused on promoting broader uses of window film through collaborations with large facilities. Building on the business experience gained from automotive products and its architectural film production base, the company intends to address demand for managing indoor environments in buildings and commercial spaces. Converting real-world applications at hotels and restaurants into further collaborations is the task ahead.

Alongside business expansion, the company places weight on improving the accessibility of sputtered film. NEXFIL's position is that films using multilayer sputtering technology should be available within the existing price range of each market. Rather than limiting such products to the high-end segment, the company says it aims to raise customer satisfaction and market value together by making high-performance films more widely available.

"We plan to expand collaborations with large facilities in the hotel, food service, and environmental sectors," NEXFIL said. "Based on our experience producing in Korea and exporting to more than 60 countries, as well as our training of installation partners, we will set a new standard for premium multilayer sputtered film in overseas markets as well."

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NEXFIL Expands Architectural Film Business into Hotels and Restaurant Chains