Dental materials company Graphy Inc.‘s five dental materials complete final review under EU Medical Device Regulation

[SOURCE] DENTALGOODNEWS (Leading Dental Industry Media, DGN) | On November 10, 2026 local time, Korean dental materials company Graphy Inc. (KOSDAQ: 318060, hereinafter referred to as "Graphy") announced that its five dental 3D printing materials have completed the final conformity assessment under the EU Medical Device Regulation (EU MDR) and are currently awaiting issuance of certification certificates. The company plans to use this as a foundation to further expand material supply and local manufacturing partnerships in the European market.

This assessment covers three materials in the TeraHarz Clear series (TC-85DAC, TA-28, TR-07) and two materials in the TeraHarz series (TC-80DC, BR-23). According to the company, the conformity assessment and final review procedures for the relevant products have been completed, and the certification process will conclude upon issuance of the certification certificates.

The EU Medical Device Regulation (Regulation (EU) 2017/745), compared with the previous Medical Device Directive (MDD), further strengthens requirements for clinical evidence, technical documentation, risk management, quality management systems, and post-market surveillance. Graphy stated that this assessment covers not only product safety and performance, but also the manufacturer's quality management system and product lifecycle safety management capabilities.

Among the materials involved in this assessment are materials used for producing shape memory clear aligners (SMA™). According to the company, SMA utilizes digital design data for direct 3D printing, providing continuous orthodontic force through the material's shape memory properties, which differs from the manufacturing method of conventional thermoformed aligners. Graphy claims to be the world's first company to commercialize directly 3D-printed shape memory aligners.

Regarding European market expansion, Graphy stated that it has established distribution partnership networks in major markets including Germany, and will further expand core material supply upon issuance of the certification certificates. In addition to direct material exports, the company plans to advance local manufacturing and distribution partnerships: local partners will use Graphy's materials and manufacturing solutions to produce and supply products under the partners' own brands or the Graphy brand. The company aims to leverage partners' existing production capacity and channels to reduce investment in building its own production facilities, while generating recurring revenue through continuous material supply.

Regarding partnerships, Graphy recently entered into a strategic collaboration with Smilers, the clear aligner brand under France's Biotech Dental, with both parties planning to explore product validation and commercialization using their materials and manufacturing technologies. Regarding other market access, the company stated that it has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance and completed registration with Brazil's National Health Surveillance Agency (ANVISA).

Graphy has also been expanding its business footprint through acquisitions and supply partnerships. According to previous DGN reporting, on August 10, 2026, Graphy signed an agreement to acquire approximately 26.14% equity in dental digital diagnostic equipment company Ray Co., Ltd. for approximately 49.2 billion Korean won (approximately RMB 236 million), becoming its largest shareholder. In this announcement, Graphy stated that after acquiring Ray, it is further expanding capabilities in digital diagnostics, software, manufacturing, and distribution. Additionally, on October 7, 2026, Graphy signed its first supply agreement worth approximately 2 billion Korean won (approximately RMB 10 million) with Korean implant company MegaGen Implant, covering dental restoration materials, 3D printing equipment, and post-processing equipment.