BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Smartooth

    DI: 08809941490008 · Model: STL-02-BK · Smartooth Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Smartooth
    Primary DI
    08809941490008
    Version / Model
    STL-02-BK
    Company Name
    Smartooth Co., Ltd.
    Labeler DUNS
    695797925
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-07-22
    Public Version
    1
    Public Version Date
    2024-07-30
    Public Version Status
    New
    Public Device Record Key
    89ea7a90-04d6-4f2c-ab48-39e8ceea2556

    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

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NBL Laser, Fluorescence Caries Detection

    GMDN Terms

    Code Name
    33995 Dental caries detector, optical induced fluorescence

    Identifiers

    Type ID
    Package 08809941490121
    Primary 08809941490008

    Customer Contacts

    Phone
    +82105182842
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K231722 000

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    5 – 40 Degrees Celsius
    Type
    Handling Environment Humidity
    Temperature Range
    15 – 90 Percent (%) Relative Humidity
    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    70 – 109 KiloPascal
    Type
    Storage Environment Temperature
    Temperature Range
    0 – 40 Degrees Celsius
    Type
    Storage Environment Humidity
    Temperature Range
    15 – 90 Percent (%) Relative Humidity
    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    70 – 106 KiloPascal