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510(k) Data Aggregation

    K Number
    K150218
    Device Name
    Fill-Up!
    Manufacturer
    COLTENE/WHALEDENT AG
    Date Cleared
    2015-06-23

    (144 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Fill-Up!

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

    Fill-Up! is indicated for - direct restoration of class I and II cavities - cavity lining - first layer for class I and II cavities - core build-ups

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a dental material (Fill-Up!), not a study describing the acceptance criteria and performance of a device. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth from this document.

    The letter merely states that the device is substantially equivalent to legally marketed predicate devices for the indicated uses. It does not contain any performance data, study designs, or statistical analyses typically found in a clinical or performance study report.

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