Smartooth

Basic Information

• Brand Name: Smartooth
• Primary DI: 08809941490084
• Version / Model: SDP-01-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: 9d5b4866-5e61-443d-8a79-266f24e0a7b0

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

• 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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NBL	Laser, Fluorescence Caries Detection	Dental	872.1745	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809941490084	GS1
Package	08809941490091	GS1	Cardboard	6	In Commercial Distribution
Package	08809941490022	GS1	Cardboard	24	In Commercial Distribution
Package	08809941490114	GS1	Cardboard	1440	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	53.5	Millimeter
Outer Diameter	13.0	Millimeter

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 – 106 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