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
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| NBL | Laser, Fluorescence Caries Detection |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| NBL | Laser, Fluorescence Caries Detection | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08809941490022 | Package | GS1 | 24 | In Commercial Distribution |
| 08809941490091 | Package | GS1 | 6 | In Commercial Distribution |
| 08809941490114 | Package | GS1 | 1440 | In Commercial Distribution |
| 08809941490084 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08809941490022 | 08809941490022 | 8809941490022 |
| 08809941490091 | 08809941490091 | 8809941490091 |
| 08809941490114 | 08809941490114 | 8809941490114 |
| 08809941490084 | 08809941490084 | 8809941490084 |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Device Sizes
| Type | Value | Unit |
|---|
| Length | 53.5 | Millimeter |
| Outer Diameter | 13 | Millimeter |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Handling Environment Atmospheric Pressure | 70 KiloPascal | 106 KiloPascal | |
| Handling Environment Humidity | 15 Percent (%) Relative Humidity | 90 Percent (%) Relative Humidity | |
| Handling Environment Temperature | 5 Degrees Celsius | 40 Degrees Celsius | |
| Storage Environment Atmospheric Pressure | 70 KiloPascal | 106 KiloPascal | |
| Storage Environment Humidity | 15 Percent (%) Relative Humidity | 90 Percent (%) Relative Humidity | |
| Storage Environment Temperature | 0 Degrees Celsius | 40 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 695797925
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 08809941490121 | Smartooth | STL-02-BK | | 2024-07-22 |
Other Devices Sharing Product Codes
smartooth.co