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510(k) Data Aggregation
K Number
K231722Device Name
SmarTooth
Manufacturer
Smartooth Co., Ltd.
Date Cleared
2024-05-01
(323 days)
Product Code
NBL
Regulation Number
872.1745Why did this record match?
Applicant Name (Manufacturer) :
Smartooth Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use as an aid in the diagnosis of dental caries
Device Description
SmarTooth (STL-02-BK) is an optical dental caries diagnostic device that uses a laser to help diagnose dental caries. The SmarTooth (STL-02-BK) is composed of 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 the detection and monitoring of dental caries lesions in teeth. The software component provides a meter with a digital read-out 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 to be introduced into the mouth of the patient for scanning of the teeth. The tooth is exposed to irradiation of a 650 nm wavelength laser by this device, and a value from the detected fluorescent light is displayed to refer to the diagnosis of dental caries. The information from the scanner is handled by the Software, which holds the interface to the user.
As a battery-operated, portable laser source with a photodiode sensor, the subject device is designed for handheld operation. 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 is used to calibrate the device before measuring the teeth.
The main body is powered by a 1.5-volt AA-type alkaline battery. This unit has two LED lamps (status and measurement), one power button, one laser output, and a beeper sounds one time when pushing the power button for 1 second to turn on and 3 seconds to turn off the device. The main body should be paired with the zero point adjustment unit on the main body holder before use to calibrate the necessary optical zero point. Users can start the measurement by clicking the "Measure" button on the application screen.
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