Dentis said Wednesday that it has obtained approval from the U.S. Food and Drug Administration (FDA) for its sheet used for clear orthodontic device, “Serafin.”

“MESHEET,” developed by Dentis, is a dental orthodontic sheet with a composite structure embedded with a mesh-structured cushioning mat, and received the final notification for approval from the FDA on Wednesday last week.

Dentis obtained a domestic patent for MESHEET last October, and has also completed application for PCT (Patent Cooperation Treaty) and individual national applications to the U.S., China, Japan, and Europe.

According to Dentis, MESHEET used a hybrid multi-layer method with layer optimization that improves traction and orthodontic retention compared to conventional sheets. Dentis has confirmed the stability and quality of MESHEET in simulated orthodontic treatment through domestic orthodontists, dental laboratories that produce transparent orthodontic devices and testing and analysis institutions.

It has been recognized for its orthodontic effectiveness in field tests conducted since July 2023. Dentis aims to launch MESHEET in the second quarter of this year.

"The core part of the transparent correction business is the material," a Dentis official said. "By developing this part independently, we could strengthen cost-competitiveness, and as patents and FDA approval have recognized the superior quality, we will enhance profitability with a unique position in the market."

With the FDA approval, Dentis will expand its reach beyond the U.S. market and pursue global B2B sales to global clear orthokeratology manufacturers and distributors. It also plans to finalize overseas patent registrations this year and begin its global expansion, starting with the U.S. market.

"Through continuous investment in material and software development, we are creating a new revenue model by building a digital clear orthokeratology platform and total digital dentistry solution," the Dentis official said. "We plan to grow Serafin as the No. 1 brand in the global clear orthokeratology market through rapid growth year after year."