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510(k) Data Aggregation

    K Number
    K020242
    Device Name
    EMULATE FAST SET AND EMULATE REGULAR SET
    Manufacturer
    CAVEX HOLLAND B.V.
    Date Cleared
    2002-04-17

    (84 days)

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

    EMULATE FAST SET AND EMULATE REGULAR SET

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

    emulate Fast Set and emulate Regular Set are dental impression materials based on alginate. They are suitable for taking impressions of the oral cavity with the purpose of constructing a gypsum model that equals the situation in the mouth. They are used for making study models, first impressions for general purpose impressions, situation models, orthodontic impressions etc.

    Device Description

    emulate Fast Set & emulate Regular Set Alginate Impression Materials

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding an alginate impression material. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods.

    Therefore, I cannot provide the requested information. The document solely focuses on the FDA's determination of substantial equivalence for the specified dental impression material.

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