Smartooth

Primary DI

08809941490121

Brand

Smartooth

Company

Smartooth Co., Ltd.

Model

STL-02-BK

Device description

SmarTooth is an optical dental caries diagnostic device that uses a laser to help diagnose dental caries. The SmarTooth comprises a portable hardware main body with batteries, a main body holder, and a mobile application. The hardware components provide a laser source, an LED indicator, and a zero point adjustment (calibration) unit to aid in detecting and monitoring dental caries lesions in teeth. The software component provides a meter with a digital readout between 0 and 99. The hardware device is a pen type device consisting of a laser diode that generates a laser and a photodiode sensor to detect fluorescent light. Both the sensor and laser diode are mounted at the tip of the device and introduced into the mouth of the patient for scanning of the teeth. The tooth is exposed to irradiation of a 650nm wavelength laser by this device, and a value from the detected fluorescent light is displayed to refer to the diagnosis of dental caries. The software handles the information from the scanner, which controls the user interface. The subject device is designed for handheld operation as a battery-operated, portable laser source with a photodiode sensor. The dental probe is a replaceable, single use component made from ABS material. This component is sized and dimensionally configured to achieve close contact with the tooth being examined. The tip ensures physical and optical contact with dentinal fluid at sites that are not readily accessible or evaluated using traditional means. The main body holder calibrates the device before measuring the teeth.The subject device is designed for handheld operation as a battery operated, portable laser source with a photodiode sensor. The dental probe is a replaceable, single use component made from ABS material. This component is sized and dimensionally configured to achieve close contact with the tooth being examined. The tip ensures physical and optical contact with dentinal fluid at sites that are not readily accessible or eval

Published

2024-07-22

Public version status

New

Distribution status

In Commercial Distribution

MRI safety

Labeling does not contain MRI Safety Information

Rx

true

OTC

false

Sterile

false

Single use

false