[Special Stock] Dentis Receives US FDA Approval... Dental-Focused Medical Devices Successively Approved for Overseas Expansion

Dentis, a medical solution company specializing in implant-based products, is showing strong performance. Its self-developed Resonance Frequency Analysis (RFA) dental implant stability measuring device, ‘ChecQ,’ has received sales approval from the U.S. Food and Drug Administration (FDA), which appears to be influencing its stock price.

As of 1:54 PM on the 24th, Dentis is trading at 8,020 KRW, up 22.82% from the previous trading day.

The dental implant stability measuring device is used to easily assess the osseointegration and stability of implants. The measurement methods are broadly divided into percussion and RFA methods. The RFA method is a next-generation technology that can compensate for stability and error issues caused by varying percussion force. Dentis Medical Device Research Institute developed the dental implant stability measuring device applying the RFA method, becoming the third worldwide and the first in Korea to do so with its own technology.

Since its launch in July last year, ChecQ has attracted significant attention in the domestic market. With FDA approval, it is expected to accelerate its entry into the global market. Currently, the company is also preparing for the European CE MDR certification for ChecQ.

Within the first half of this year, Dentis is preparing CE-MDR certification for its core dental equipment, including ChecQ, the dental unit chair ‘LUVIS CHAIR,’ the painless anesthesia device ‘DENOPS,’ and Korea’s first portable intraosseous anesthesia device ‘DENOPS-I.’ The strategy is to complete all preparations by the first half and further expand global market growth in the second half.

A Dentis representative stated, "Since last year, Dentis’s excellent technology has been recognized in the global market through overseas approvals such as FDA and CE for major new products." They added, "This year, starting with ChecQ, we will successfully carry out preparations for global market expansion and achieve performance growth through aggressive sales strategies by overseas subsidiaries in the U.S., India, and other countries."

Dentis is focusing on strengthening its overseas sales network to lead new global growth by announcing plans to establish new subsidiaries in Thailand, Vietnam, Japan, and Poland, following existing ones in the U.S., China, Spain, Portugal, Malaysia, and India. With consecutive overseas approvals of key new products and active sales activities through subsidiaries, global growth potential is expected to be enhanced.