The company is awaiting final certification to expand its European manufacturing and distribution partnerships for its dental materials.
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 (EU MDR). The company is now awaiting the issuance of the certificates.
The anticipated European certification builds on Graphy’s existing international regulatory clearances. The company previously secured US FDA 510(k) clearance and registration with Brazil’s National Health Surveillance Agency. Graphy plans to use the European certification to further strengthen its materials supply and local business partnerships across the region.
Five Materials Pass Review
The assessed materials include 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 EU MDR sets strict requirements for clinical evidence, technical documentation, risk management, quality management systems, and post-market surveillance.
“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,” says Un seob Sim, chairman of Graphy, in a release. “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.”
European Expansion and Partnerships
The certification progress supports Graphy’s strategy to expand its supply of dental 3D printing materials in Europe, including those used to produce its shape memory aligners. The aligners combine direct 3D printing from digital design data with shape-memory properties designed to deliver sustained orthodontic forces.
Graphy is pursuing a business model that pairs local manufacturing and distribution partnerships with a recurring materials supply. Under this model, local partners manufacture and supply dental products using Graphy’s materials and solutions, which reduces the need for direct investment in local manufacturing facilities.
A recent example of this strategy is Graphy’s 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 materials and manufacturing technologies.
Photo: Graphy
