AccessGUDID - DEVICE: Smartooth (08809941490084)

GUDID

Device Identifier (DI) Information

Brand Name: Smartooth
Version or Model: SDP-01-BK
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Smartooth Co., Ltd.

Primary DI Number: 08809941490084
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 695797925 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
33995	Dental caries detector, optical induced fluorescence	A 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.	Active	false

FDA Product Code

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Product Code	Product Code Name
NBL	Laser, Fluorescence Caries Detection

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Temperature: between 0 and 40 Degrees Celsius
Storage Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

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Size Type Text
Length: 53.5 Millimeter
Outer Diameter: 13.0 Millimeter

Device Record Status

Public Device Record Key: 9d5b4866-5e61-443d-8a79-266f24e0a7b0
Public Version Date: July 30, 2024
Public Version Number: 1
DI Record Publish Date: July 22, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
08809941490091	6	08809941490084	In Commercial Distribution	Cardboard
08809941490022	24	08809941490084	In Commercial Distribution	Cardboard
08809941490114	1440	08809941490022	In Commercial Distribution	Cardboard