DentMedi Co., Ltd

DentMedi Co., Ltd specializes in dental zirconia materials, which are ceramic substances used primarily for creating dental restorations like crowns and bridges. These materials are engineered to provide high strength, biocompatibility, and aesthetic appeal for prosthetic applications in dentistry.

DentMedi Co., Ltd is based in South Korea (KR). The company’s focus on dental zirconia materials reflects its specialization in providing solutions tailored for dental professionals, particularly within the European market where its products are registered.

DentMedi Co., Ltd’s dental zirconia material is listed in the EUDAMED database, which is the European Union’s medical device registry. This registration aligns with the company’s compliance efforts under the EU Medical Device Regulation (MDR) for its Class IIa devices.

DentMedi Co., Ltd’s dental zirconia material is classified as Class IIa under the EU Medical Device Regulation. This classification is based on its intended use—high-strength, biocompatible dental restorations—which requires a higher level of scrutiny than Class I devices but does not pose the same risks as higher-risk Class IIb or Class III devices.