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3M™ ProPlus System, like the predicate devices, is designed for making precise crown and bridge and denture impressions.

3M™ ProPlus System is composed of three hydrophilic vinyl polysiloxane dental impression materials. The system includes a tray material and two wash materials with different viscosities. The base and catalyst are extruded from two-part cartridges through a mixing tip. The pastes are inserted into the mouth and they cure into a rigid dental impression. 3M™ ProPlus System tray and wash materials are specially formulated to meet the demands of the heavy body/light body impression technique. The tray material may also be used in combination with 3M Imprint™ monophase materials.

The provided text is a 510(k) summary for a dental impression material (3M™ ProPlus System), not an AI/ML device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria, study data, sample sizes, expert qualifications, or ground truth for an AI/ML device.

The document describes the product, its intended use, and compares it to predicate devices using bench tests for material properties. It concludes that the device is safe and effective based on these bench tests and safety analysis.

No information regarding AI/ML device performance, acceptance criteria, or study details as outlined in the prompt can be extracted from this document.

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