Smartooth Co., Ltd.

Smartooth Co., Ltd. specializes in dental caries detectors that use optical induced fluorescence technology. These devices are designed to help dentists identify early-stage tooth decay in clinical settings by detecting fluorescence patterns in teeth, improving diagnostic accuracy for cavities.

Smartooth Co., Ltd. is headquartered in the United States. Its devices are authorised for use in the US, where they undergo regulatory oversight through the FDA’s Class II designation and are listed via 510(k) and UDI registrations.

Smartooth’s devices fall under FDA Class II classification, which applies to products that pose moderate risk but require performance standards or special controls to ensure safety and effectiveness. This classification is typical for diagnostic devices like caries detectors, where precision and reliability are critical but not as high-risk as surgical implants.

Smartooth’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries ensure traceability and compliance with US regulatory requirements for medical devices.