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The Champions Implants MIMI 1-Piece Precision Implant is intended to support single or multi-unit restorations in both long-term and temporary applications throughout the maxillary and mandibular arches. The MIMI 1-Piece Precision Implant is indicated for immediate loading when there is good primary stability and an appropriate occlusal load. The MIM1 1-Piece Precision Implants have diameters from 4,0 to 4,5mm and are available in length of 10 to 16mm.

The MIM® 1-Piece Precision Implant is a one piece endosseous dental implant. The thread lengths are 10mm to 16mm. The diameters are 4,0mm and 4,5mm.

This document does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.

The provided text is a 510(k) summary for the "Champions Implants MIMI® 1-Piece Precision Implant," which is a dental implant system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than on performance metrics typically associated with AI/ML devices.

Therefore, I cannot extract the requested information regarding acceptance criteria or a study proving device performance because it is not present in the provided text.

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