Camx Triton Hd Proxi Head
by Duerr Dental AG 510(k)
Active
510(k) K172007
Overview
The Camx Triton Hd Proxi Head is a caries detector that uses laser light and transmission. It is a dental device used for the early detection and diagnosis of interproximal caries. The device is part of an interchangeable head system, allowing for easy change between caries diagnosis and intraoral imaging.
The Camx Triton Hd Proxi Head is supplied as part of the Camx Triton Hd system and is used in dental settings. It is a diagnostic tool that does not use X-ray radiation, making it suitable for patients such as pediatric and pregnant patients. The device has been cleared with the FDA 510K authorization.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK172007 | Date22 Nov 2017 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- NTK
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.1745
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from Duerr Dental AG
Questions
What is the CamX Triton HD Proxi Head used for?
The CamX Triton HD Proxi Head is used for the early detection and diagnosis of interproximal caries, making it a valuable tool in dental settings.
Is the CamX Triton HD Proxi Head suitable for all patients?
The device is suitable for patients such as pediatric and pregnant patients because it does not use X-ray radiation.
How is the CamX Triton HD Proxi Head supplied?
The CamX Triton HD Proxi Head is supplied as part of the CamX Triton HD system, allowing for easy change between caries diagnosis and intraoral imaging.
What regulatory authorization has the CamX Triton HD Proxi Head received?
The CamX Triton HD Proxi Head has received FDA 510K authorization, indicating it is substantially equivalent to a predicate device.