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510(k) Data Aggregation

    K Number
    K213932
    Device Name
    A-dec 300, A-dec 500
    Manufacturer
    A-dec, Inc.
    Date Cleared
    2022-03-02

    (76 days)

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

    A-dec 300, A-dec 500

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

    The A-dec Delivery System is intended to provide a mounting location to providing arr, water, vacuum, and electrical power to dental devices for use during diagnostic treatment by licensed health care professionals. Delivery systems may be mounted to dental carts, dental cabinets, and walls.

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but this document does not contain the information requested in your prompt. The document is an FDA 510(k) clearance letter for the A-dec 300 and A-dec 500 Delivery Systems, which are dental operative units.

    The letter discusses regulatory classifications, general controls, and compliance requirements for these devices. It also includes an "Indications for Use" section.

    However, the document does not describe any AI/device performance study, acceptance criteria, or related data such as sample sizes, expert qualifications, ground truth establishment, or MRMC studies. The device cleared is a dental operative unit and accessories, not an AI-powered diagnostic or assistive device that would typically undergo the type of performance studies you are asking about.

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