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510(k) Data Aggregation

    K Number
    K152051
    Device Name
    ClearMet
    Manufacturer
    Mycone Dental Supply Co., t/a Keystone Industries
    Date Cleared
    2016-03-22

    (243 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ClearMet

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

    Fabrication of removable dental prosthetic devices, such as full and partial dentures, occlusal splints and night guards.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the "ClearMet" device, which is a denture relining, repairing, or rebasing resin.

    This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies.

    The letter primarily confirms that the FDA has reviewed the 510(k) submission for ClearMet and determined it to be substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements and contact information for the applicant.

    Therefore, I cannot provide the requested information based on this document.

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