KELLS AI Dental Scan receives medical device approval in Singapore

· · 4 mins read
KELLS AI Dental Scan receives medical device approval in Singapore © theyoungdentist.com
KELLS AI Dental Scan receives medical device approval in Singapore © theyoungdentist.com
Singapore's Health Sciences Authority has approved KELLS AI Dental Scan as a Class B medical device, allowing direct-to-consumer AI dental screening and opening new possibilities for preventive oral health.

KELLS AI Dental Scan is now officially registered as a Class B medical device with Singapore's Health Sciences Authority (HSA), making it the first AI-powered dental screening tool in the country cleared for direct use by consumers. The company says this registration confirms the validity of its proprietary dental AI technology and supports its expansion in Singapore. This step is both a commercial and regulatory milestone as reported in the company announcement.

With this approval, people in Singapore can now use their smartphones for dental screening, without needing to visit a clinic first. KELLS has developed its AI to analyze photos of teeth taken on a phone, flagging possible oral health issues and advising users when to see a dentist. The system is designed for direct consumer use: users take photos of their teeth, the AI reviews them, and the app highlights any concerns and suggests if a professional checkup is needed, according to the official release.

Singapore's HSA maintains a public registry of medical devices, listing each product's registration number, risk class, and intended use-demonstrating that AI-based medical software undergoes a formal regulatory process in the country.

"Dental care has traditionally been centered around what happens inside the dental office, but much of oral health happens between visits," said Jie Feng, Ph.D., Co-Founder and CEO of KELLS. For people who have trouble getting timely dental care-such as young children, older adults, or those in underserved communities-this technology could help close the gap. By making dental screening possible at home, at work, or in community settings, KELLS aims to connect early detection with professional care.
In Singapore, KELLS has already introduced its technology through community and workplace oral health programs, showing that digital screening can reach large groups and help guide people from early identification to in-person care. The HSA registration also confirms that KELLS meets clinical and quality management standards, and it may help the company expand internationally. The Singapore HSA's device registry, referenced by the Cyber Security Agency of Singapore, shows that AI-based medical software is classified by risk class. Other AI medical products in Singapore are already listed as Class C, so this classification is being used in practice according to the official product list.
KELLS AI Dental Scan is part of a broader effort to make oral health easier to track and understand for consumers. The platform helps users monitor changes over time, make decisions about care, and connect with providers. "AI can help people identify potential concerns earlier and make more informed decisions about when and where to seek care," Feng said.

In September 2026, the Saudi Food and Drug Authority granted marketing authorization to two locally developed AI medical systems for dentistry and ophthalmology, highlighting the rapid acceleration of AI regulation in medical diagnostics across the region.


With this regulatory approval, KELLS is set to change how dental care is delivered in Singapore and potentially elsewhere. The move reflects a growing demand for accessible, preventive tools that let people take charge of their oral health. As AI-driven diagnostics become available to consumers, dental care is shifting toward continuous, tech-enabled monitoring and earlier intervention.
Topics: Oral Health and Prevention Diagnostics and Imaging Product Updates Singapore Dentistry #AI Clinical Decision Support #Artificial intelligence in dentistry #Dental AI Validation
Nora Mercer Digital dentistry and technology editor The Young Dentist
Author

Nora Mercer

Nora Mercer is Digital Dentistry & Dental Technology Editor at The Young Dentist, covering dental AI, imaging, intraoral scanning, CAD/CAM, 3D printing and connected clinical workflows. She focuses on what technologies actually change in practice and separates independent evidence from technical specifications, clinician experience and manufacturer claims.