Today Odne announced that it received clearance from the U.S. Food & Drug Administration for its endodontic debridement device, Odne Clean. The FDA regulates such devices as class II medical devices, which are subject to premarket notification via the 510(k) pathway.
Odne Clean 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. Odne Clean 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, Odne Clean supports minimally invasive root canal treatments enabling endodontists and dentists to preserve as much tooth structure as possible. First clinical study results indicate that Odne Clean results in less post-operative pain compared to other techniques.
Odne’s Chief Operating Officer and co-founder, Mark Bispinghoff, comments: “With the clearance of Odne Clean, 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 the efficient collaboration in performing the extensive testing the FDA requires.”
In 2023, Odne received FDA-clearance for Odne Fill, its innovative root canal obturation technique. Odne Fill is the first light-curing root canal filler that instantly photo-cures upon applying Odne Cure, a high-precision laser curing light. The three Odne products are a game-changing technology platform for minimally invasive Root Preservation Therapy (RPT) allowing endodontists and dentists to accelerate treatment and increase patient comfort.
“We are thrilled 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 initiated its Priority Access Program for innovative Root Preservation Therapy (RPT) at the AAE annual meeting in Los Angeles. The PAP will form the core of Odne’s scientific & clinical community, transforming endodontics. One initiative of the PAP is to perform a clinical case registry, collecting further knowledge on the clinical use of Odne’s devices for root canal treatment. Participating Endodontists get the privilege of being amongst the first users of Odne’s devices and provide valuable use-related and scientific feedback.
