Identity
- Trade Name
- Smartooth FDA UDI
- Generic Name
- Dental caries detector, optical induced fluorescence FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- SDP-01-BK FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809941490084 FDA UDI
- FDA Product Code
- NBL FDA UDI
- GMDN Term
- Dental caries detector, optical induced fluorescence FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1745 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 53.5 Millimeter FDA UDIOuter Diameter — 13.0 Millimeter FDA UDI
Category: Dental caries detector, optical induced fluorescence
Smartooth by Smartooth Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Smartooth Co., Ltd.
Sources (1)
- FDA UDI 9d5b4866-5e61-443d-8a79-266f24e0a7b0 36 fields · synced Jun 6, 2026