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510(k) Data Aggregation

    K Number
    K092319
    Device Name
    STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387
    Manufacturer
    DANVILLE MATERIALS, INC.
    Date Cleared
    2009-09-16

    (43 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387

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

    The device is an additional-cure viny| polysiloxane dental impression material that is used for all crown and bridges, edentulous and Implant techniques.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental impression material named "Star VPS, First Half, First Quarter." This document is a regulatory approval letter, not a study report or clinical trial result.

    Therefore, the requested information about acceptance criteria, device performance, study details (sample sizes, provenance, ground truth, experts, adjudication, MRMC, standalone performance, training set) cannot be extracted from this document, as it does not contain such information.

    The document primarily states that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices for the indicated uses. The indications for use are provided: "The device is an additional-cure vinyl polysiloxane dental impression material that is used for all crown and bridges, edentulous and Implant techniques."

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