ZURICH, August 27, 2024 /PRNewswire/ — Odne today announced that it has received FDA approval for its endodontic removal device, Odne™Clean. 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 disinfection rinse1. 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,” he says Andreas SchmockerCEO 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.
