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510(k) Data Aggregation

    K Number
    K020206
    Device Name
    INTRAORAL CAMERA ME-15
    Manufacturer
    DENT CORP. RESEARCH & DEVELOPMENT
    Date Cleared
    2002-04-11

    (79 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    INTRAORAL CAMERA ME-15

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

    The ME-15 Intraoral Camera use only for photographing from a full mouth to a signal tooth. The ME-15 is not intended for any other use.

    Device Description

    Intraoral Camera ME-15

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving device performance for the "Intraoral Camera ME-15." The document is a 510(k) premarket notification clearance letter from the FDA, indicating that the device has been deemed "substantially equivalent" to legally marketed predicate devices.

    This type of FDA clearance relies on demonstrating substantial equivalence, not necessarily on new studies proving acceptance criteria for performance metrics. Therefore, the requested information elements cannot be extracted from this document.

    The document states:

    • Trade/Device Name: Intraoral Camera ME-15
    • Regulation Name: Dental Operative Unit and Accessories
    • Indications For Use: The ME-15 Intraoral Camera is for photographing from a full mouth to a single tooth. It is not intended for any other use.

    To fulfill the request regarding acceptance criteria and performance study, the original 510(k) submission document would be needed, which is not provided here.

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