Dentis 'Seraphin', First in Korea to Obtain Transparent Orthodontic CE MDR Certification

Dentis, an implant-based digital dentistry company (CEO: Sim Gibong), announced on the 21st that its subsidiary TNS has obtained the European Medical Device Regulation (CE MDR) certification for the transparent aligner SERAFIN.

Through this CE MDR certification, Dentis has successfully established a foothold for entering the global market. The company plans to accelerate the launch of SERAFIN in overseas markets, starting with Europe and Southeast Asia, within this year.

The certification was led by Dentis's subsidiary, the orthodontics specialist company TNS (CEO: Jang Wongun), and final approval was received on the 10th. The European Union's Medical Device Regulation (MDR) strengthens requirements for technical documentation, clinical evaluation, and post-market surveillance and supervision compared to the previous Medical Device Directive (MDD). It has been newly applied since May 2021 to enhance the safety of medical devices.

According to TNS, the CE MDR certification involves more rigorous clinical evaluations than the previous MDD method, and the certification process, including post-market management and control, is very stringent throughout the entire export and distribution process of medical device products. Accordingly, the company began preparing for certification from the official application of CE MDR after the official launch of SERAFIN and succeeded in obtaining certification after about 1 year and 9 months.

SERAFIN is Korea's first digital transparent aligner platform service, developed in April 2021 by TNS based on its outstanding clinical experience and specialized technology in the orthodontics field. After Dentis was listed, it incorporated TNS as a subsidiary and actively marketed SERAFIN based on the company's long clinical experience and know-how, raising its recognition as a leading domestic transparent aligner brand. Furthermore, it succeeded in expanding production capacity and stabilizing manufacturing quality by automating parts of the transparent aligner production process for the first time in Korea.

Dentis and TNS have designated the transparent aligner field as a strategic business and have proactively responded to the rapidly growing transparent aligner market. The two companies plan to further advance the technology of the SERAFIN platform service this year through software updates and material development. They also intend to speed up preparations for expanding the product lineup, strengthening automated processes, enhancing clinical education programs, and hosting symposiums to increase market share and enter the global market.

A Dentis representative stated, “This CE MDR certification is the result of recognition of the company's excellent manufacturing quality and clinical technology regarding the safety and efficacy of SERAFIN.” He added, “Dentis is also proceeding with the process for U.S. Food and Drug Administration (FDA) certification, and based on the externally recognized product reliability, plans to accelerate global market entry as the representative brand of K-transparent aligners.”