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510(k) Data Aggregation

    K Number
    K161734
    Device Name
    Vanguard Dental Unit
    Manufacturer
    RITTER CONCEPT GMBH
    Date Cleared
    2016-12-09

    (169 days)

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

    Vanguard Dental Unit

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

    The Vanguard Dental Unit is intended to supply power to and serve as a base for dental devices; and accessories. It is intended for use in the dental clinic /office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a dental unit. It does not contain any information about acceptance criteria or a study proving that an AI/ML device meets those criteria.

    The document solely focuses on:

    • Device: Vanguard Dental Unit
    • Regulation Number: 21 CFR 872.6640 (Dental Operative Unit and Accessories)
    • Regulatory Class: Class I
    • Product Code: EIA
    • FDA Determination: Substantially equivalent to legally marketed predicate devices.
    • Indications for Use: To supply power to and serve as a base for dental devices and accessories, intended for use in dental clinics/offices by trained personnel, and attached to a dental chair.

    Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for an AI/ML device.

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