Dental and medical solutions company Dentis (CEO Ki-bong Shim) announced that its premium implant product 'AXEL' has received approval from the U.S. Food and Drug Administration (FDA).
With this approval, AXEL has secured entry into the US market, following its European CE certification last year. Dentis explained that this has laid the foundation for expanding product sales in key global markets, the US and Europe.
The company expects this FDA approval will allow it to fully expand its global business strategy, focusing on premium products. Furthermore, the company stated that the local infrastructure development, distribution channel expansion, and brand investment efforts since the establishment of its US subsidiary are now more likely to yield tangible results.
AXEL features a strong screw structure and enhanced initial fixation, designed to ensure stable implantation in a variety of bone environments. Furthermore, its compatibility with existing dental implant systems simplifies surgical procedures and enhances user convenience for medical professionals.
Pre-clinical evaluations conducted in the US have also yielded positive responses, and based on pre-approval demand, rapid sales growth is expected following FDA approval. Dentis plans to expand its local sales and distribution network by holding product launch events and clinical seminars, focusing on the western US.
Dentis is also pursuing entry into the large-scale dental service organization (DSO) market. Based on AXEL's performance and clinical efficiency, Dentis aims to secure competitiveness in the premium segment of the DSO market, which is currently dominated by major global brands.
In addition, Dentis plans to simultaneously target the full-arch reconstruction treatment market. Following AXEL, Dentis plans to sequentially launch the 'Multi Unit PRO' for prosthetic connection and the 'AXEL All-on-X Surgical KIT', a surgical kit dedicated to full-arch reconstruction, in the first half of the year, thereby strengthening its All-on-X treatment solution.
In the global dental implant market, competition is intensifying, focusing on premium products and digital dental solutions, and competition among companies is expanding in terms of technological prowess and brand awareness.
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