Odne receives approval for medical device in the USA

Odne has received approval from the US Food Drug Administration (FDA) for its debridement device for root canal treatment called Odne Clean. According to a company statement, this medical device offers a novel approach to root canal disinfection that simplifies and speeds up the process. It creates a hydrodynamic cavitation cloud inside the root canal using only saline solution as the main rinsing medium. Unlike the harsh chemical disinfectants currently in use, Odne Clean 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.

In 2023, the spin-off of the two Swiss Federal Institutes of Technology in Zurich (ETH) and Lausanne(EPFL) had already received FDA approval for Odne Fill to fill the root canal. According to the information provided, it is the only one that hardens immediately when Odne Cure, a high-precision laser curing light, is applied. "With the approval of Odne Clean, we now have US market approval for our entire product portfolio for root canal treatment," co-founder and Chief Operating Officer Mark Bispinghoff is quoted as saying.

Odne Clean can now be integrated into the company's first user program in the USA. As part of this, a case register will be kept in order to "build up further clinical evidence", according to co-founder and CEO Andreas Schmocker. Odne is headquartered in Dübendorf and has a branch in Gettysburg, Pennsylvania. ce/mm