Smartooth
SmarTooth STL-02-BK is a portable handheld optical device for dental caries assessment. Its hardware includes a laser source, an indicator and a zero-point calibration unit, with a mobile…
SmarTooth STL-02-BK is a portable handheld optical device for dental caries assessment. Its hardware includes a laser source, an indicator and a zero-point calibration unit, with a mobile application.
The FDA indication is use as an aid in diagnosing dental caries. The filing describes a replaceable, single-use probe designed to contact the tooth being examined.
Listed Item
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
Operating Principle
The device emits 650 nm red laser light onto a tooth surface. The filing says fluorescence from carious tissue produces scale readings on the system display, with readings available through the mobile application.
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Carl Zeiss Meditec (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Smartooth Co., Ltd., South Korea |
|---|---|
| FDA product code | NBL |
| Device type | Light-Induced Fluorescence Caries Detector |
| Device class | Class 2 |
| Regulation | 21 CFR 872.1745 |
| Establishment | Manufacturer |
| 510(k) | K231722 |
| Record published | 2024-07-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 5 to 40 °C; Handling environment humidity 15 to 90 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature 0 to 40 °C; Storage environment humidity 15 to 90 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal |
| Packaging | Cardboard of 6, cardboard of 24, cardboard of 1440, cardboard of 48 |
| Sizes | Length 53.5 mm; outer diameter 13 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SDP-01-BK | Length 53.5 mm | In distribution |
| STL-02-BK | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Acteon | Sopro | 13 |
| Trios | 3SHAPE Trios A/S | 6 |
| Trios 5 | 3SHAPE Trios A/S | 3 |
| DIAGNOcam Vision Full HD | Kavo Dental Gmbh | 2 |
| CS 1600 | Carestream Health, Inc. | 1 |
| Primescan 2 | Sirona Dental Systems Gmbh | 1 |
| Fluorescence Mode | Carl Zeiss Suzhou Co., Ltd. | 1 |
| CamX Spectra Handpiece | Dürr Dental SE | 1 |
| Primescan 2 Multiuse Sleeve | Sirona Dental Systems Gmbh | 1 |
| Fluorescence Mode | Carl Zeiss Meditec (Suzhou) Co., Ltd. | 1 |
| Ortek Therapeutics, Inc. | Ortek Therapeutics, Inc. | 1 |
| Aiobio | Aiobio Co., Ltd. | 1 |
Showing 12 of 18. All products under Light-Induced Fluorescence Caries Detector
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231722 | 2024-05-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.