Identity
- Trade Name
- CamX Spectra Caries Detection Aid FDA UDI
- Generic Name
- Dental caries detector, optical induced fluorescence FDA UDI
- Device Name
- The CamX Spectra Fluorescence Caries Detection Aid System aids in the diagnosis of caries. It consists of a toothbrush-sized handpiece for examining the condition of a tooth, an umbilical cord connecting the handpiece to a computer and imaging software. FDA UDI
- Model / Reference
- G4100 FDA UDI
- Description
- The CamX Spectra Fluorescence Caries Detection Aid System aids in the diagnosis of caries. It consists of a toothbrush-sized handpiece for examining the condition of a tooth, an umbilical cord connecting the handpiece to a computer and imaging software. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D678G41000 FDA UDI
- 510(k) Number
- K090169 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Category: Dental caries detector, optical induced fluorescence
CamX Spectra Caries Detection Aid by Air Techniques, Inc. — 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
- Air Techniques, Inc.
Sources (1)
- FDA UDI f3992f2f-b115-43d0-88be-03c7ba1a054b 36 fields · synced Jun 9, 2026