Graphy Completes Final EU MDR Review for Five TeraHarz Dental Materials, Awaits Certificates

Graphy Inc. has completed the final conformity assessment review for five of its dental 3D printing materials under the European Union's Medical Device Regulation and is awaiting issuance of the certificates, the company said in a PR Newswire announcement dated November 10, 2026. The Seoul-based company, listed on KOSDAQ under 318060, sells proprietary photopolymer resins for orthodontics and restorative dentistry, centered on its Shape Memory Aligner materials.

The Five TeraHarz Materials Under Review

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). Graphy said the conformity assessment and final review procedures are complete, and the certification process will conclude once the certificates are issued.

The EU Medical Device Regulation (Regulation (EU) 2017/745) sets stricter requirements than the previous Medical Devices Directive, particularly for clinical evidence, technical documentation, risk management, quality management systems and post-market surveillance. Graphy said the assessment covers device safety and performance as well as manufacturers' quality management systems and their ability to manage safety throughout the product lifecycle.

"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."

Graphy said it has been expanding its local distribution network and partnerships in key European markets, including Germany. A recent example is its strategic partnership with Smilers, the clear aligner brand of France-based Biotech Dental, which aims to explore product validation and commercialization opportunities using Graphy's materials and manufacturing technologies.

Graphy's Revenue and Funding Record

According to akta.pro company records, Graphy generated approximately $11 million in revenue over the trailing 12 months as of early 2026, following its 2025 KOSDAQ IPO. The same records show a loss of approximately $7.5 million in the year preceding the IPO, with negative net margins, and total funding of $16.4 million across five rounds, the last a $3.4 million round in December 2024.

Graphy's Moves Before the EU Review

Graphy completed its acquisition of a 26.14% stake in Ray on September 16, 2026, and inaugurated Sim Un-Seob as chairman of both companies on September 18, 2026, EIN Presswire reported. In August 2026, Graphy signed a memorandum of understanding with MegaGen Implant for strategic cooperation and product supply and distribution, with the companies planning to finalize a three-party main contract in September, according to Nate News. Graphy became Ray's largest shareholder after acquiring a 26% stake along with management rights for 49.2 billion won, Nate News reported in August 2026.

What Follows Certificate Issuance

Graphy said that once the certificates are issued it plans to accelerate the supply of its core materials and pursue new commercial opportunities in Europe, including closer cooperation with European partners. The company also cited U.S. FDA 510(k) clearance and registration with Brazil's National Health Surveillance Agency (ANVISA) as regulatory clearances in major markets.