Spident Achieves Most European CE MDR Certifications, Boosting Global Market Presence
SEOUL, South Korea – Spident is rapidly accelerating its expansion into the global market by significantly increasing its lineup of products certified under the European Medical Device Regulation (CE MDR). The newly certified products include composite and flowable resins such as 'EsFlow Plus', 'EsFlow', and 'EsCom100', as well as bonding and restorative agents including 'K-Bond Universal', 'EsBond', and 'Core.it Dual'. The certification also covers luting and temporary cements ('EsCem RMGI', 'EsCem', and 'EsTemp Implant'), endodontic materials ('Vioseal' and 'Seal.it'), and the base material 'Base.it'. These product groups represent Spident’s core portfolio, featuring numerous flagship products widely used by local dental clinics.With this latest round of additional certifications, Spident has established a comprehensive certification framework for a total of 14 products. This achievement allows the company to secure a solid MDR certification foundation across all its major product lines, including restoratives, bonding agents, cements, and endodontic materials. The CE MDR is the European Union's medical device regulation that replaces the previous Medical Device Directive (MDD). It introduces much stricter requirements across the board, including rigorous clinical evaluations, safety and efficacy validations, and post-market surveillance (PMS). Medical device manufacturers must undergo more demanding verification processes for product performance and safety, which has reportedly caused challenges for many medical device companies worldwide trying to secure the certification. Industry experts evaluate the CE MDR certification as a key benchmark demonstrating a company’s quality control capabilities and technological prowess, given the high level of verification required. "Securing MDR certification for 14 items demonstrates that Spident possesses a quality management system and technological capabilities that meet global standards," the company explained. A Spident representative stated, “We expect this additional CE MDR certification to serve as a momentum to enhance product reliability not only in the European market but also in the global dental market. With these 14 MDR-certified products as our foundation, we plan to focus heavily on expanding our footprint in Europe and other overseas markets.”
2026-06-19