De Corematrix Co., Ltd.

De Corematrix Co., Ltd. specializes exclusively in zirconia dental ceramics. These materials are engineered for dental restorations such as crowns, bridges, and inlays, providing high-strength, biocompatible solutions for patients. The focus is on durable and aesthetically pleasing dental applications.

De Corematrix Co., Ltd. is based in China. Its devices are regulated under Chinese medical device laws, and while they are listed in the EU’s eudamed database, compliance with EU regulations (such as MDR or IVDR) would depend on individual device authorizations. The company’s products are not inherently EU-approved; each device’s compliance is determined by its specific regulatory pathway.

De Corematrix Co., Ltd.’s zirconia dental ceramics are registered in the eudamed database, which is the EU’s central registry for medical devices. This listing indicates the device’s presence in the EU market, but it does not imply authorization—only that it is tracked for transparency and compliance purposes under EU regulations.

De Corematrix Co., Ltd.’s zirconia dental ceramics are classified as Class IIa medical devices. This classification is based on their intended use (dental restorations) and associated risk levels, as determined by regulatory authorities. Class IIa devices typically require additional scrutiny beyond general medical device regulations but are not considered high-risk like Class III devices.