(132 days)
The Microlux Transilluminator is a device used upon initial examination of the dental patient to help locate crown fractures, posterior and anterior caries.
The Microlux Transilluminator is a screening device used to help locate caries and crown fractures. It also functions as an auxiliary light source to aid in operative procedures and preventive dentistry.
The Microlux Transilluminator consists of a battery powered, high output L.E.D. light source, (three 'N" size batteries are included) and a fiber-optic glass light guide with either a 3mm or 2mm tip. The fiber-optic glass light guide snaps into the light source. The fiber-optic light guide is autoclaveable. The light source can be wiped with disinfectant. Disposable custom fitted sleeves are also available the cover the entire unit to prevent cross contamination.
The provided text is a 510(k) summary for the Microlux Transilluminator, a device used to aid in visualizing caries and crown fractures. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The 510(k) summary focuses on establishing substantial equivalence to legally marketed predicate devices, primarily highlighting the difference in light source technology (LED vs. halogen/incandescent lamps). It does not describe any performance studies or clinical trials with acceptance criteria, sample sizes, ground truth establishment, or expert evaluations.
Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them based on the given input.
§ 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.