FDA clearance for a root canal cleaning device that uses saline water as the primary cleaning medium
ZURICH , Aug. 27, 2024 /PRNewswire/ — Odne today announced that it has received FDA approval for the Odne™Clean endodontic removal device. The FDA regulates devices as Class II medical devices, which are subject to premarket notification through the 510(k) pathway.
Odne™Clean offers a new approach to root canal disinfection, simplifying and speeding up the process. Creates a hydrodynamic cavitation cloud within the root canal using only saline (sodium chloride) as the primary irrigating medium. The cavitation jet removes debris inside the canals and tubules and increases the effect of the final NaOCl rinse disinfection1. Odne™Clean has the potential to reduce the risk of adverse reactions caused by harsh chemical disinfectants commonly used in root canal disinfection. With a 190 µm tip, the thinnest dental fluid delivery tip on the market, Odne™ Clean supports minimally invasive root canal treatments that allow endodontists and dentists to preserve as much tooth structure as possible. The results of the first clinical study show that Odne™ Clean results in less postoperative pain compared to other techniques 1.
Odne’s Chief Operating Officer and Co-Founder, Mark Bispinghoff, comments: “With the licensing of Odne™Clean, we now have US market approval for our full portfolio of root canal preservation (RPT) products. We are very proud of our team for going the extra mile and would like to thank our partners for effectively working together to carry out the extensive testing required by the FDA.”
In 2023, Odne received FDA clearance for Odne™Fill, the innovative root canal occlusion technique. Odne™Fill is the first light-curing root canal filler that is light-cured directly by the application of Odne™ Cure, a high-precision laser curing light. Odne’s three products are a game-changing technology platform for minimally invasive root preservation therapy (RPT) that enables endodontists and dentists to accelerate treatment and increase patient comfort.
“We are excited to now integrate Odne™Clean into our Priority Access Program and make it available to our US customer base,” says Andreas Schmocker, CEO and co-founder. “Our goal with the program is to continue to build strong clinical evidence and, together with our clinicians, we will transform endodontics with a passion for innovation and scientific and clinical excellence.”
Odne recently launched the Priority Access Program for its innovative Root Preservation Therapy (RPT) at the AAE Annual Meeting in Los Angeles. PAP will form the core of Odne’s scientific and clinical community, transforming endodontics. A PAP initiative is to conduct a clinical case registry, gathering further knowledge about the clinical use of Odne’s devices for root canal treatment. Participating Endodontists are privileged to be among the early adopters of Odne devices and provide valuable usage information and scientific feedback.
1 Internal preclinical and clinical data on file
About Odne
Odne AG (formerly Lumendo AG), has its roots in a pioneering collaboration between two renowned Swiss institutions: the Swiss Federal Institutes of Technology in Lausanne and Zurich (EPFL & ETH Zürich). Founded in 2018, Odne’s journey began by licensing cutting-edge technology assets from these esteemed institutes.
Odne is committed to pioneering the future of endodontics through advanced technology and innovative solutions. Endodontics, the branch of dentistry that deals with root canal treatments, has been marred by complexity and unpredictability. Odne is on a mission to change that.
Root canal treatments have long posed challenges for dentists, with traditionally low success rates ranging from 46% to 91%. With more than 60 million annual treatments worldwide, these failures result in significant healthcare costs. Odne’s technology platform seeks to address these issues by offering treatment options for both dentists and their patients. Launched in the US in April 2024, Odne’s medical device portfolio addresses problems such as cleaning and obturation of complex root canal morphologies. Recently, Odne Inc, USA was established to support the launch in the USA.
Odne is backed by venture capital funds focused on healthcare and dentistry. These include Revere Partner (NY), an independent venture fund that provides capital for cutting-edge innovations in oral and systemic health, and NV Capital (LIE), a family-owned venture capital boutique that led the Series A financing. In addition to the main investors, other famous funds such as Dental Innovation Alliance (DIA), Plug&Play, Hatcher, Züricher Kantonalbank, as well as various family offices and angel investors are supporting the launch of Odne in the US market.
Odne’s technology platform for root preservation therapy (RPT), including: the first hydrodynamic cavitation device that uses saline as the primary cleaning agent and the first all-in-one, light-cured filling material.
Disclaimer: Odne™Fill, Odne™Cure and Odne™Clean are cleared for use in the US only.
For more information contact:
Holger Essig, General Manager / Head of Global Marketing
Odne AG, Ringstrasse 14, 8600 Dübendorf, Switzerland
holger.essig@odne.co | www.odne.co | +41 79 320 1056
Note to editors: Odne Inc. high resolution images and logo. available upon request.
SOURCE Odne Inc.
