Identity
- Trade Name
- CamX Triton HD, SPECTRA Head FDA UDI
- Generic Name
- Dental caries detector, optical induced fluorescence FDA UDI
- Model / Reference
- J2710 FDA UDI
Identifiers
- Primary DI / UDI-DI
- E247J27101 FDA UDI
- 510(k) Number
- K150672 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
Yes
FDA UDI
Category: Dental caries detector, optical induced fluorescence
CamX Triton HD, SPECTRA Head by Dürr Dental Se — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental caries detector, optical induced fluorescence.
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- CamX Spectra Caries Detection Aid — Air Techniques, Inc. · Class II
- DIAGNOdent pen 2190 US — KaVo Dental GmbH · Class II
- DEXIS CariVu 3-in-1 by KaVo — KaVo Dental GmbH · Class II
- DIAGNOdent 2095 — KaVo Dental GmbH · Class II
- DEXIS CariVu — KaVo Dental GmbH · Class II
Cleared under the same submission
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
- Dürr Dental Se
Sources (1)
- FDA UDI 4ff0e2a0-edc3-4f7f-8788-31fb721c88cd 33 fields · synced Jun 8, 2026