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510(k) Data Aggregation

    K Number
    K994077
    Device Name
    AROMA FINE (NORMAL AND FAST SET)
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2000-01-27

    (56 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Aroma Fine is a dust free alginate impression material used for taking impressions to obtain a detailed reproduction of the oral anotomy.

    Device Description

    Aroma Fine is a dust free alginate impression material

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental impression material called "Aroma Fine." It states that the device is substantially equivalent to legally marketed predicate devices. However, the letter does not contain any information regarding acceptance criteria, study details, device performance, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The document is a regulatory approval, not a scientific study report.

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