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510(k) Data Aggregation

    K Number
    K963766
    Device Name
    3M PROPLUS SYSTEM
    Manufacturer
    3M COMPANY
    Date Cleared
    1996-10-31

    (42 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K882690,K863287,K940379,K880849
    Why did this record match?
    Reference Devices :

    K882690,K863287,K940379,K880849

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

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

    Device Description

    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.

    AI/ML Overview

    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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