FDA.reportPublic FDA data

Smartooth

Primary DI
08809941490084
Brand
Smartooth
Company
Smartooth Co., Ltd.
Model
SDP-01-BK
Device description
The Disposable Probe is the tip of the Smartooth (STL-02-BK) main body. This component is composed of a sensor tip, the part in direct contact with the tooth for diagnosing tooth decay and where the laser is output, and the connecting part that connects to the main body.
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809941490022PackageGS124In Commercial Distribution
08809941490091PackageGS16In Commercial Distribution
08809941490114PackageGS11440In Commercial Distribution
08809941490084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809941490022088099414900228809941490022
08809941490091088099414900918809941490091
08809941490114088099414901148809941490114
08809941490084088099414900848809941490084

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length53.5Millimeter
Outer Diameter13Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+8225182842smartooth@smartooth.co

Regulatory Flags#

DUNS number
695797925
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809941490008SmartoothSTL-02-BK2024-07-22
08809941490121SmartoothSTL-02-BK2024-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E27668082030Primescan 2SIRONA Dental Systems GmbHNBL2025-11-21
E27668082450Primescan 2SIRONA Dental Systems GmbHNBL2025-10-23
E27668053651Primescan 2 Multiuse SleeveSIRONA Dental Systems GmbHNBL2025-09-16
E27668558402Primescan 2SIRONA Dental Systems GmbHNBL2025-08-20
05902729754149TRIOS 53shape Trios A/SNBL2025-06-16
E27668020400Primescan 2SIRONA Dental Systems GmbHNBL2025-05-16
05902729753906TRIOS Ready Tip3shape Trios A/SNBL2025-05-06
06977585090143Fluorescence ModeCarl Zeiss Meditec (Suzhou) Co., Ltd.NBL2025-03-26
04262352350035DI ScanZetta25 AGNBL2025-02-21
EKAV101537000DIAGNOcam Vision Full HDKaVo Dental GmbHNBL2024-12-03
08800043200090AIOBIOAIOBIO CO.,LTDNBL2024-12-02
08809941490008SmartoothSmartooth Co., Ltd.NBL2024-07-22
08809941490121SmartoothSmartooth Co., Ltd.NBL2024-07-22
03760278267587ACTEONSOPRONBL2024-05-02
EKAV101112130DIAGNOcam Vision Full HDKaVo Dental GmbHNBL2024-02-01
EKAV101315000DIAGNOcam Vision Full HDKaVo Dental GmbHNBL2024-02-01
00858197004062Ortek Therapeutics, Inc. ORTEK THERAPEUTICS, INCNBL2022-12-21
05902729753661TRIOS3shape Trios A/SNBL2022-09-26
05902729753753TRIOS3shape Trios A/SNBL2022-09-26
05902729753746TRIOS3shape Trios A/SNBL2022-09-26
05902729753678TRIOS3shape Trios A/SNBL2022-09-26
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
05902729753784TRIOS3shape Trios A/SNBL2022-09-26
E247J27121CamX Spectra Interchangeable HeadDÜRR DENTAL SENBL2022-03-04
08800025400135InspireGOOD DOCTORS CO., LTD.NBL2020-11-13
03760278260304ACTEONSOPRONBL2019-03-13