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510(k) Data Aggregation

    K Number
    K983661
    Device Name
    BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES
    Manufacturer
    BELMONT EQUIPMENT CORP.
    Date Cleared
    1999-01-12

    (85 days)

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

    BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES

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

    DENTAL UNIT AND ACCESSORIES ARE INTENDED FOR THE DENTISTS, AND DENTAL ASSISTANTS FOR TRADITIONAL AND NORMAL PATIENT PROCEDURES IN THE DENTAL OPERATORY. THE DESIGN FUNCTION, AND POSITIONING OF THE UNIT AND ACCESSORIES ARE SIMILAR TO MOST ALL OTHER DENTAL UNITS MANUFACTURED FOR THIS SPECIFIC PURPOSE OVER THE PAST TWENTY YEARS.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

    The provided document is a 510(k) clearance letter from the FDA for a dental unit and accessories, stating that the device is substantially equivalent to legally marketed predicate devices. It covers regulatory aspects, product codes, and general information about marketing the device, but it does not delve into the specific details of performance studies or acceptance criteria.

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