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510(k) Data Aggregation

    K Number
    K082294
    Device Name
    WESTAR SERIES DENTAL UNITS
    Manufacturer
    WESTAR MEDICAL PRODUCTS, INC.
    Date Cleared
    2008-08-22

    (10 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Westar Series Delivery Units are intended to be used by Dentists, Hygienists, and Dental Assistants, to supply power and utilities to, and serve as a base for, dental instruments and tools for traditional and normal patient treatment procedures in the dental operatory.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, I cannot provide the requested information. The document is a 510(k) clearance letter from the FDA for Westar Series Dental Units. It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, the letter does not contain any information regarding:

    • Specific acceptance criteria.
    • Details of a study proving device performance against acceptance criteria.
    • Sample sizes for test or training sets.
    • Data provenance.
    • Number or qualifications of experts.
    • Adjudication methods.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies.
    • Standalone algorithm performance.
    • Type of ground truth used or how it was established.

    This document is a regulatory approval, not a scientific study report.

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