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510(k) Data Aggregation

    K Number
    K051243
    Device Name
    JET BLUE BITE
    Manufacturer
    COLTENE/WHALEDENT AG
    Date Cleared
    2005-06-23

    (41 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

    Impression material for bite registration and registration of centric occlusion

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental impression material called "Jet Blue Bite." This document primarily addresses the substantial equivalence of the device to a predicate device and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot extract the requested information from this document.

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