16 Sep 2026
KELLS AI Dental Scan clears Singapore HSA Class B as consumer AI screening tool
KELLS said its AI Dental Scan was registered as a Class B medical device with Singapore’s Health Sciences Authority. The company frames the tool as a smartphone photo scan that uses proprietary AI to flag possible oral-health concerns and guide people toward professional care when needed.
HEALTH desk — same-day company primary that a consumer AI dental screening product cleared a named national medical-device registration (Singapore HSA Class B), expanding AI oral-health tools beyond the dental chair into phone-based screening.
Company claim, as the same wire has it: the registration makes KELLS AI Dental Scan Singapore’s first HSA-registered AI dental screening tool designed for direct consumer use.
Product, still company: people capture images of their teeth with a smartphone. KELLS’ proprietary AI analyzes the photos to identify potential oral-health concerns and help users understand what may need attention and when professional care may be appropriate.
What the registration is for, company: the wire says the milestone supports KELLS’ expansion in Singapore and advances preventive oral healthcare beyond traditional dental-office settings. The same page says KELLS technology has been deployed through community and corporate oral-health initiatives in Singapore, as a way to reach groups outside the chair and connect people who need further care with dental professionals.
Named voice on the release: Jie Feng, Ph.D., cofounder and CEO of KELLS. He says dental care has traditionally been centered on what happens inside the dental office, but much of oral health happens between visits, and that this registration validates years of technology development and moves toward a future where people can understand and manage their dental health continuously. His other quotes are color only and stay in Sources.
About-box context, optional and company-attributed: KELLS calls itself an AI-powered dental care and benefits platform. The about box says it combines AI, clinical expertise, and an integrated digital care experience so members can detect potential concerns earlier, navigate care, and stay supported through their dental-health journey.
Plain English for the rest of the card: HSA = Health Sciences Authority, Singapore’s medical-device regulator. Class B = HSA’s risk class for this device category — not a U.S. FDA class and not a 510(k). AI Dental Scan = phone photos in, an AI oral-health map out. screening tool = software meant to flag possible concerns, not a substitute for a dentist visit. 510(k) = the common U.S. FDA path that clears a device as substantially equivalent to something already on the market — this filing is not that path.
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On 16 Sep 2026 KELLS announced that KELLS AI Dental Scan was registered as a Class B medical device with Singapore’s Health Sciences Authority (HSA). The company PRIMARY is KELLS’ PR Newswire release “KELLS AI Dental Scan Registered as Class B Medical Device with Singapore HSA,” dated September 16, 2026, 09:04 ET, SOURCE KELLS, and datelined SINGAPORE and NEW YORK. HSA is Singapore’s national medical-device regulator. Class B is HSA’s risk class for this device category — not a U.S. Food and Drug Administration (FDA) class, and not a 510(k). That company wire is the filing event. These are company claims.