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Airlight Dental Handpiece Series, models M600 and M800 are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.

The Airlight Dental Handpiece is a high speed dental handpiece with a lightly textured finish for enhanced grip. It is a hand-held, channeled instnument that is powered by compressed air that is delivered through a hose to an air channel is the handpiece. This impels the turbine in the head of the handpiece to nevolve in Other internal channels deliver air and water to the head for cleaning and cooling. Any common dental bur is held in place in the handpiece head by a push-buttong There are three major parts which are made metal: a standard turbine, the threaded connector at the back end which attaches to the standard air/water hose in the dental unit, and the internal tubes that carry the chip air and water. The new three parts are substantially equivalent to those in the predicate device. Similar to the predicate device, the Airlight Dental Handpiece must be cleaned and lubricated with a quality commercial dental handpiece cleaner/lubricant. It is supplied non-sterile, but must be sterilized before use, as with the predicate device. It will be packaged as a single unit or in multiples.

The provided text describes a 510(k) summary for the Beves Dental Canada Inc. Airlight Dental Handpiece Series. It does not contain any information regarding acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

The document merely states that the "Discussion of Non-Clinical Tests Performed" involved testing according to ISO 7785-1:1997 and ISO 9168:1991, and explicitly mentions "Discussion of Clinical Tests Performed: None." This indicates that the device was cleared based on substantial equivalence to predicate devices and non-clinical performance standards, not on clinical performance demonstrating achievement of specific acceptance criteria.

Therefore, I cannot fulfill your request for the detailed table and study information as it is not present in the provided text.

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