Odne has received approval from the US Food & Drug Administration (FDA) for Odne Clean, its debridement device for root canal treatment. According to a company statement, the medical device offers a novel approach to root canal disinfection that simplifies and speeds up the process.
It works by creating a hydro-dynamic cavitation cloud inside the root canal using only saline solution as the main irrigation medium. Unlike the harsh chemical disinfectants currently in use, OdneClean is designed to reduce the risk of unwanted side effects and post-operative pain. With the thinnest dental fluid delivery tip on the market, this device enables minimally invasive root canal treatments, explains the statement.
In 2023, the spin-off from the Swiss Federal Institutes of Technology in Zurich (ETH) and Lausanne (EPFL) received FDA approval for Odne Fill for filling the root canal. According to the statement, it is the only product that instantly photo-cures when Odne Cure, a high-precision laser curing light, is applied.
“With the clearance of Odne Clean, we now have US market approval for our complete product portfolio for root canal preservation,” Mark Bispinghoff, Odne’s Chief Operating Officer and co-founder, is quoted as saying. Odne Clean can now be integrated into the company’s Priority Access Program, explains CEO and co-founder Andreas Schmocker. “Our goal with the program is to continue to build strong clinical evidence,” he is quoted as saying. Odne has premises in Gettysburg in the US state of Pennsylvania. ce/mm
Related news
Meet with an expansion expert
Our services are free of charge and include:
- Introduction to key contacts in industry, academia, and government
- Advice on regulatory framework, taxes, labor, market, and setting up a company
- Custom-made fact-finding visits, including office and co-working space