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510(k) Data Aggregation

    K Number
    K974894
    Device Name
    KROMATICA COLOR CHANGING ALGINATE
    Manufacturer
    MATECH, INC.
    Date Cleared
    1998-02-12

    (43 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

    The Intended Use: This material is to be used by the dentist to produce an impression of a person's mouth/teeth and then a plaster material is poured into this impression to create a cast of the patient's mouth/ teeth.

    Device Description

    Kromatica Color Changing Alginate

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the "Kromatica Color Changing Alginate" impression material (K974894). It states that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about acceptance criteria, specific performance metrics, or study details.

    Therefore, I cannot provide the requested information. The document focuses solely on the regulatory clearance for marketing based on substantial equivalence. It does not include data from a clinical or performance study that would define acceptance criteria or device performance.

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