Dentistry Today
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Cube Click Secures FDA Approval for SMILE Dx
Cube Click, Inc. is excited to announce that its flagship medical device, SMILE Dx, has received official approval from the U.S. Food and Drug Administration (FDA). SMILE Dx is a next-generation, AI-powered diagnostic platform that identifies cavities (caries), root canals (periapical radiolucencies), and periodontal disease at the radiographic pixel level.
“The dental AI imaging market is growing at a compound annual growth rate (CAGR) of 22.3%. If SMILE Dx captures just 2% of this $3.1 BILLION market, that translates to $62 MILLION in annual revenue,” said Dr. Richard Ricci, CEO of Cube Click. “At a conservative 5x revenue multiple, SMILE Dx could command a $310 MILLION valuation. Under a more optimistic 10x multiple, that valuation rises to $620 MILLION—highlighting the significant upside potential for early investors.”
According to the FDA, dentists routinely misdiagnose over 20% of cavities and root canal pathologies. SMILE Dx directly addresses this challenge, delivering an average 19% improvement in diagnostic detection, as confirmed by multiple clinical studies. The platform’s cloud-based AI system not only enhances clinical outcomes but also drives practice growth by increasing patient engagement and acceptance of treatment plans.
