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The Kreativ Mach Series Air Abrasion systems are used for cavity preparation in Classes I, II, III, IV, and V. The uses include removal of tooth structure and restorative dental materials, and site preparation for pit and fissure sealant therapy and bonding of porcelain and ceramic. They are also used for restoration prophylaxis.

The Mach 5, Mach 5 plus, Mach 6 are pneumatic devices which combine pressurized air and aluminum oxide powder to produce a high velocity stream of particles to perform dental restorative procedures, including preparation for pit and fissure sealant and composite restorations. The units are capable of removing dental caries, old restoration materials, as well as healthy enamel and dentin to prepare the tooth surface for subsequent adhesion of restorative materials. The abrasive particulate is delivered via a small handpiece which is approximately the size of a high speed dental drill. The systems are designed for ease of service and maintenance with readily accessed and refillable canisters for the particulate supply.

The provided text describes a 510(k) submission for dental devices (Mach 5, Mach 5 plus, Mach M, and Mach 6) and focuses on demonstrating substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study designed to prove the devices meet specific performance criteria in the way that an AI/ML device submission would.

Therefore, I cannot provide the requested table and study details. The document is a regulatory submission demonstrating substantial equivalence, not a performance study against predefined acceptance criteria for the devices' operational output.

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