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Announcing 510(K) Clearance of Our uLab Software Platform

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Led by a talented team of entrepreneurs, technologists and commercial developers behind a number of successful companies, including the original clear aligner technology, our team has come together to develop the next generation of digital dental software.

As of today, our patented orthodontic treatment planning software just received U.S. FDA clearance. We hope to create a better diagnosis and treatment planning experience for orthodontists and their patients. You can check out the full press release on Business Wire, or read it below.


uLab Systems, a privately held digital dental company focused on the development of its patented automated orthodontic treatment planning software, announced U.S. FDA clearance today. The uLab system is a breakthrough orthodontic diagnosis and treatment planning platform designed for use by dental professionals. The uLab software seamlessly imports patient 3-D digital scans and allows dental professionals to diagnose the orthodontic treatment needs of their patients and rapidly develop a treatment plan chairside in less than 5 minutes. In addition, the software exports standard STL files for printing of dental models to create aligner trays and retainers in the dental professional’s office.

The uLab software is the next generation in orthodontic treatment software. “This novel software is designed to accelerate the pace that dental professionals can diagnose and create customized treatment plans for their patients. With uLab, it will now be possible for professionals to complete a treatment plan in less than 5 minutes. What’s more, patients will be able to begin treatment on the same day as their initial consultation. uLab empowers dental professionals to create a more positive patient experience,” said uLab Co-Founder and President, Charlie Wen. Dr. Tim Dumore was the lead investigator on the clinical study completed in field. “Based on my experience, uLab is positioned to revolutionize how orthodontists practice, by providing control over how clear aligner cases are treated. uLab decreases the burden of aligner treatment planning by allowing orthodontists to design treatment plans in just minutes. At the same time, uLab expands the range of cases that can be treated with aligners by allowing orthodontists to precisely control how many aligners they require, along with making integrated hybrid aligner-braces treatment simple.”

uLab will begin commercialization in the U.S. prior to American Association of Orthodontics conference in Washington DC in May of 2018. For additional product information, or to begin the order process, please email your inquiries to info@ulabsystems.com.

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