Relu, a pioneer in artificial intelligence (AI)-assisted segmentation for dental labs and software companies, proudly announces the dual achievement of 510(k) clearance by the U.S. Food and Drug Administration (FDA) and CE Mark approval by an EU Notified Body. These regulatory milestones authorize the commercial distribution of the Relu Creator, a cutting-edge dental tool that enables users to create 3D anatomical models of patients in just minutes.
RELU CREATOR CE FDA (PRNewsfoto/Relu)
FDA clearance signifies compliance with U.S. medical device standards, while the CE Mark confirms adherence to EU regulations for product safety and consumer protection. This dual recognition underscores Relu’s commitment to excellence in the oral health sector.
“We are thrilled to have attained both FDA and CE approval for the Relu Creator,” stated Adriaan Van Gerven, CTO and co-founder of Relu. “These significant achievements are a testament to Relu’s dedication to creating superior technology that meets the highest international safety and quality standards. We’re poised to revolutionize patient and dentist experiences across both continents.”
“This approval paves the way for our advanced technology to enter the U.S. and EU dental markets with the highest potential for growth. Having led strategy in the dental, AI, and orthodontic sectors, I consider this achievement a key differentiator that sets the Relu Creator apart. This is a major step forward in Relu’s mission to modernize dental care,” said Bindu Saran, former global head of orthodontic technology at Straumann, former senior manager of R&D at Ormco, and board member at Relu.
The Relu Creator integrates cutting-edge AI to deliver features such as automated anatomical identification and enhanced 3D imaging for dental diagnostics and treatment planning. By improving precision and increasing overall efficiency in dental procedures, the Relu Creator is set to be an essential tool for modern dental clinics.
About Relu
Founded in 2019 with the vision of making dental treatments safer and faster, Relu uses advanced computer vision and artificial intelligence to automate manual workflows. Their Relu Engine and Relu Creator are used by dental lab and software partners in thousands of orthodontic and implant treatments every day.
Relu is headquartered in Leuven, Belgium, with an office in Boston, MA, USA.
Learn more at relu.eu.
