ZÜRICH , Aug. 27, 2024 /PRNewswire/ -- Today Odne announced that it received clearance from the U.S.
Food & Drug Administration for its endodontic debridement device, OdneTMClean. The FDA regulates such devices as class II medical devices, which are subject to premarket notification via the 510(k) pathway. OdneTMClean offers a novel approach to root canal disinfection, simplifying and accelerating the process.
It creates a hydro-dynamic cavitation cloud inside the root canal using only saline solution (sodium chloride) as the main irrigation medium. The cavitation jet removes debris inside the canals and tubules and increases the effect of the final disinfection rinse with NaOCl 1 . OdneTMClean has the potential to reduce the risk of adverse events caused by harsh chemical disinfectants commonly used during root canal disinfection.
With its 190 μm tip, the thinnest dental fluid-delivery tip on the market, OdneTMClean supports minimally invasive root canal treatments enabling endodontists and dentists to preserve as much tooth structure as possible. First clinical study results indicate that OdneTMClean results in less post-operative pain compared to other techniques 1 . Odne's Chief Operating Officer and co-founder, Mark Bispinghoff, comments: "With the clearance of OdneTMClean, we now have US market approval for our complete product portfolio for Root Canal Preservation (RPT).
We are very proud of our team for going the extra mile and would like to thank our partners for .