Lumendo received clearance for its endodontic root canal filler from the U.S. Food & Drug Administration (FDA). Based on this clearance, Lumendo can legally market the filler for permanent root canal obturation in the U.S.A.
The FDA clearance results from a diligent, 5-year research, testing, and improvement process and targeted collaboration between the team, suppliers, and testing laboratories. It is the most important milestone the company founded in 2018 as a spin-off from EPFL and ETH Zurich has achieved so far and a significant step ahead in revolutionizing the way root canal treatments are done. Achieving FDA clearance in less than 2 months signifies the high standards that Lumendo adheres to, ensuring the safety and performance of its products.
The clearance of Lumendo's flagship product has solidified its on-time commercial launch, planned for Q2 2024. By launching the world's first injectable, instant light-curable, hydrophilic endodontic filler, Lumendo aims to enable dentists and endodontists to obturate root canals with ease and confidence."
Root canal (endodontic) treatments are among the most difficult for dentists and carry the risk of application errors which can significantly reduce success rates. With more than 60 million annual treatments worldwide, it is crucial to make these treatments a success and, at the same time, optimize healthcare costs.
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