(145 days)
The SOPROLIFE is indicated as an aid in the diagnosis of dental caries and as an intra oral camera to visualize anatomical details invisible to the naked eye or with mirror.
The SOPROLIFE is a fluorescence caries detection device . This device is a fluorescence detector housed in a dental handpiece, and a control unit that performs device calibration, as well as variable tone emitting and fluorescence measurement functions.
The handbiece can be connected with 5 different control units : Dock M VIDEO Dock M USB2. Dock MU VIDEO, Dock MU USB2, Dock USB2.
The SOPROLIFE is a device used in clinical dental applications to observe the condition of hard dentinal tissues.
As the SOPROLIFE can be adapted to the most complex of clinical situations, it quickly helps the dentist to get a complete analysis as it adjusts treatment options in Diagnosis aid mode. In Treatment aid mode, the SOPROLIFE facilitates observation of the dentinal tissue condition in progress and at the end of the treatment. In daylight mode the SOPROLIFE enables the dentist to visualize anatomical details invisible to the naked eye or with mirror like an intra oral camera SOPRO 595.
This document is a 510(k) summary for the SOPROLIFE device, a fluorescence caries detection device. It outlines the device description, intended use, indications for use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot extract the requested information from the provided text. The document is primarily a regulatory submission for premarket notification, establishing substantial equivalence to existing devices rather than detailing the results of performance studies against specific acceptance criteria.
§ 872.1745 Laser fluorescence caries detection device.
(a)
Identification. A laser fluorescence caries detection device is a laser, a fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as well as variable tone emitting and fluorescence measurement functions. The intended use of the device is to aid in the detection of tooth decay by measuring increased laser induced fluorescence.(b)
Classification. Class II, subject to the following special controls:(1) Sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;
(2) Premarket notifications must include clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and
(3) The labeling must include detailed use instructions with precautions that urge users to:
(i) Read and understand all directions before using the device,
(ii) Store probe tips under proper conditions,
(iii) Properly sterilize the emitter-detector handpick before each use, and
(iv) Properly maintain and handle the instrument in the specified manner and condition.