Cube Click, Inc. Secures FDA Approval for SMILE Dx—A Game-Changer in Dental AI Diagnostics

FDA-Cleared Medical Device Unlocks Major Revenue Potential for Dentists and Investors Alike

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 the 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.

Investment Highlights:

• First and only FDA-approved dental AI device compatible with both digital and phosphor plate sensors.
• First and only FDA-approved system for detecting primary, secondary, and gross caries.
• 6 awarded U.S. patents + 3 pending patents, reinforcing strong intellectual property protection.
• Cloud-based recurring revenue model, positioned for rapid market penetration and scale.
• Our Team Built SMILE Dx on time and on budget.

“SMILE Dx® represents a significant market disruptor,” said Dr. Andrea Cambria, CFO of Cube Click. “By dramatically improving diagnostic accuracy and treatment acceptance rates, we are unlocking substantial new revenue streams for dental practices—while creating a highly scalable, subscription-based business model for Cube Click.”

About Cube Click, Inc.

Cube Click, Inc. develops advanced AI-powered medical devices that empower dental professionals to achieve new levels of diagnostic precision and profitability. Its flagship product, SMILE Dx, is at the forefront of transforming dental care through AI innovation.

Learn more at SMILEDx.ai.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250618124158/en/

FDA-Cleared Medical Device: SMILE Dx® Unlocks Major Revenue Potential for Dentists and Investors Alike