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This air-powered dental handpiece is intended for removal of carious material, cavities and crow preparations, removal of filings, processing of tooth, restoration of surfaces and as a surgical tool for third molar removal procedures. It is designed for use by a trained professional in the field of general dentistry.

The Maxima PRO 45L air-driven handpieces are air driven dental handpieces for the use by a trained professional in the field of general dentistry. The devices are air-powered handpieces that are reusable and ergonomically shaped. The devices can be sterilized by the gravity steam autoclave methods that have been validated. Through the coupling connected to a dental unit, the proposed dental handpiece receive air for functionality of the high speed turbine. They also receive cooling water for cutting through one port and light for illumination through another port. Further one there is a jet needle supplied with the Maxima PRO 45L. By using this part the operator is able to clean the spray port in the head of the product if there is an insufficient amount of cooling water out of the Maxima PRO 45L according to the instructions for use. The mechanism of action for the proposed air driven handpieces is as follows: The dental handpieces is an air-driven handpiece which will be supplied with water, air and light through the tube and the coupling of a dental treatment unit. The handpiece is operated by pneumatic pressure applied on the cartridge, providing a rotation between 380,000 and 420,000 rpm. For proper operation, set air pressure on the dental treatment unit at 40 ± 1.45 psi and check with a pressure gauge Air supply must be dry, clean, and uncontaminated. For the cooling water, a minimum of 50 ml/min (pressure 14.5 ± 1.5 psi (1± 0.1) of water is needed. The Multiflex coupling has a bulb which enables thought existing optical fiber in the handpiece, the lighting at the place of action of the drill. Dental burs (not part of this 510(k)) according to ISO 1797-1 type 3 could be inserted into the chuck system of the turbine. The Maxima PRO 45L interacts with the patient through a rotating bur with the patient teeth according to the intended use. The Maxima PRO 45L is providing with connection MULTIflex system. The connectors carry the air for the high speed turbine, the cooling water for cutting treatment and light for illumination from the dental treatment unit. The coupling is an accessory that permits quick exchange of the work equipment and high costeffectiveness when extending your range of instruments. As a matter of course each dental instrument can be ergonomically rotated 360° on the MULTIflex coupling. The MULTIflex connectors are accessories to the medical device which will not be delivered together with the Maxima PRO 45L.