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ART-L2 uses the optical characteristics of the light to generate radial spectrum of the bulb to go through the optical lens and produce appropriate radial light power density via optical fiber and projected on the mixed resin of dentistry filling substances special filling material to achieve tooth filling effect.

ART-L2 LIGHT CURING UNIT

The provided text is an FDA 510(k) clearance letter for the ART-L2 Light Curing Unit. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the acceptance criteria or details of a study proving the device meets those criteria, nor does it include information about the performance claims, clinical studies, or AI components requested in the prompt.

The document is a regulatory approval notice, not a scientific publication detailing performance evaluation. Therefore, I cannot extract the requested information from the provided text.

To answer your request, I would need a different type of document, such as a full 510(k) submission, a scientific paper, or a clinical trial report that describes the device's performance characteristics and the studies conducted to validate them.

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