Odne announced that it received clearance from the FDA for its endodontic debridement device, OdneClean. The FDA regulates such devices as class II medical devices, which are subject to premarket notification via the 510(k) pathway.
OdneClean offers a novel approach to root canal disinfection. 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.
In 2023, Odne received FDA-clearance for OdneFill, its innovative root canal obturation technique. OdneFill is the first light-curing root canal filler that instantly photo-cures upon applying OdneCure, 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.
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.
