LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K024105
    Device Name
    VELOPEX AQUACUT FLUID ABRASION UNIT
    Manufacturer
    VELOPEX INTERNATIONAL, INC.
    Date Cleared
    2003-10-09

    (300 days)

    Product Code
    KOJ
    Regulation Number
    872.6080
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VELOPEX AQUACUT FLUID ABRASION UNIT

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

    FOR PIT AND FISSURE SEALANTS. PREPARATION REMOVAL AND RESICRATION OF COMPOSITS . CAVITY PREPARATION. CLEANING, POLISHING AND STAIN REMOVAL,

    Device Description

    Not Found

    AI/ML Overview

    The provided FDA letter for K024105, "Velopex Aquacut Fluid Abrasion Unit," does not contain any information about acceptance criteria or a study proving the device meets said criteria.

    The letter is a 510(k) clearance letter, which focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance study results against specific acceptance criteria.

    Therefore, I cannot answer the questions regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for either the test or training sets, as this information is not present in the provided document.

    The document only states the "Indications For Use" which are:

    • FOR PIT AND FISSURE SEALANTS. PREPARATION
    • REMOVAL AND RESTORATION OF COMPOSITES.
    • CAVITY PREPARATION.
    • CLEANING, POLISHING AND STAIN REMOVAL.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1