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

- Link: https://www.thailand-business-news.com/pr-news/graphy-completes-final-ce-mdr-review-for-five-key-dental-3d-printing-materials-and-awaits-certificate-issuance
- Published: 2026-11-11T09:46:00+07:00
- Author: PR Newswire

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**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.

 [⌊Graphy's TeraHarz Clear and TeraHarz dental 3D printing materials, which have completed the final conformity assessment review under the EU Medical Device Regulation (EU MDR).⌉](https://mmx.prnasia.com/media/MS2032555/Graphy-CE-MDR.jpg?id=OA3071640&p=medium600)

Graphy’s TeraHarz Clear and TeraHarz dental 3D printing materials, which have completed
the final conformity assessment review under the EU Medical Device Regulation (EU
MDR).

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](https://www.thailand-business-news.com/pr-news/ckyoon@itgraphy.com)
| [digwack@itgraphy.com](https://www.thailand-business-news.com/pr-news/digwack@itgraphy.com)
| [jheonlee@itgraphy.com](https://www.thailand-business-news.com/pr-news/jheonlee@itgraphy.com)
[https://www.itgraphy.com](https://www.itgraphy.com/) 

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