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510(k) Data Aggregation

    K Number
    K011666
    Device Name
    CHILLIT
    Manufacturer
    HEATSHIELD, INC.
    Date Cleared
    2001-08-06

    (68 days)

    Product Code
    EAT,DYJ,EKZ,MLY
    Regulation Number
    872.1720
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CHILLIT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
      1. COOLING HEAT SENSITIVE ORTHODONTIC WIRES
      1. TOPICAL ANESTHETIC
      1. PULP TEST THE VITALITY OF TEETH
    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device named "Chillit." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    The letter is a regulatory approval, stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It discusses general controls, regulations, and contact information for further inquiries.

    Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them based on the provided text. The document simply does not contain that type of information.

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