Odne receives FDA clearance for endodontic debridement device

The device creates a hydrodynamic cavitation cloud inside the root canal using only sodium chloride as the main debridement medium. The cavitation jet removes debris inside the canals and tubules and increases the effect of the final disinfection rinse with sodium hypochlorite solution.

OdneClean can potentially reduce the risk of adverse events caused by harsh chemical disinfectants commonly used during root canal disinfection. With its 190 µm tip, the thinnest on the market, OdneClean supports minimally invasive root canal treatments, enabling endodontists and general dentists to preserve as much tooth structure as possible. Initial internal clinical study results suggest that OdneClean leads to less postoperative pain compared with other techniques.

Odne’s chief operating officer and co-founder, Dr Mark Bispinghoff, commented in a press release: “With the clearance of OdneClean, we now have US market approval for our complete product portfolio for root canal preservation. 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 OdneFill, its innovative root canal obturation material. OdneFill is the first endodontic obturation material to be cleared by FDA that is injectable and light-curing. It instantly polymerises upon applying OdneCure, a high-precision microlaser. The three Odne products offer a game-changing technology platform for minimally invasive Root Preservation Therapy, allowing dental professionals to accelerate treatment and increase patient comfort.

Odne recently initiated its priority access programme for Root Preservation Therapy at the annual meeting of the American Association of Endodontists in Los Angeles in the US. The programme will form the core of Odne’s scientific and clinical community. One initiative of the programme is to create a clinical case registry to collect further knowledge on the clinical use of Odne’s devices for root canal treatment. Participating endodontists will have the opportunity to be among the first users of Odne’s devices and to provide valuable user-related and scientific feedback.

“We are thrilled to now integrate OdneClean into our [priority access programme] and make it available to our US customer base,” said Dr Andreas Schmocker, CEO and co-founder of Odne. “Our goal with the programme 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,” he concluded.

More information about Odne can be found here.

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