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510(k) Data Aggregation

    K Number
    K111828
    Device Name
    CLEARSPLINT ES
    Manufacturer
    ASTRON DENTAL CORPORATION
    Date Cleared
    2011-10-26

    (120 days)

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

    CLEARSPLINT ES

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

    Clearsplint ES is a heat cured, moldable, acrylic compound for use in the fabrication of dental appliances and dental prostheses devices including TMJ splint appliances, night guards, bruxism appliances and other devices as prescribed.

    Device Description

    Clearsplint ES is a heat cured, moldable, acrylic compound.

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a dental material called "Clearsplint ES." This document does not contain information about acceptance criteria, device performance described by specific metrics, or any studies using AI or human readers.

    Therefore, I cannot provide the requested information based on the input. The document is strictly a regulatory approval for a medical device (a dental material), stating that it is substantially equivalent to a predicate device. It does not describe any performance studies or AI-related assessments.

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