Smartooth

Primary DI
08809941490008
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NBLLaser, Fluorescence Caries Detection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBLLaser, Fluorescence Caries DetectionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231722000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231722000SmarToothSmartooth Co., Ltd.2024-05-01NBL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809941490121PackageGS148In Commercial Distribution
08809941490008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809941490121088099414901218809941490121
08809941490008088099414900088809941490008

GMDN Terms#

Term, Definition table
TermDefinition
Dental caries detector, optical induced fluorescenceA mains electricity (AC-powered) device designed to determine the changes in the fluorescence of teeth enamel and dentine due to mineral loss, mainly for the diagnosis of early stage dental caries and/or to monitor the progress of caries. It consists of a light source (typically a laser) that elicits fluorescence in teeth, and a unit that quantifies the altered fluorescence of the carious tooth tissue.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal109 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+82105182842smartooth@smartooth.co

Regulatory Flags#

DUNS number
695797925
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809941490121SmartoothSTL-02-BK2024-07-22
08809941490084SmartoothSDP-01-BK2024-07-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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E27668020400Primescan 2SIRONA Dental Systems GmbHNBL2025-05-16
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06977585090143Fluorescence ModeCarl Zeiss Meditec (Suzhou) Co., Ltd.NBL2025-03-26
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05902729753685TRIOS3shape Trios A/SNBL2022-09-26
05902729753722TRIOS 53shape Trios A/SNBL2022-09-26
05902729753739TRIOS 53shape Trios A/SNBL2022-09-26
05902729753760TRIOS3shape Trios A/SNBL2022-09-26
05902729753777TRIOS3shape Trios A/SNBL2022-09-26
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E247J27121CamX Spectra Interchangeable HeadDÜRR DENTAL SENBL2022-03-04
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