LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K024094
    Device Name
    4 SEASONS
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2003-02-14

    (65 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    4 Seasons is intended to be used for:

    • Anterior restorations (Classes III, IV) .
    • . Class V restorations (cervical caries, root erosion, wedged-shaped defects)
    • . Restorations in the posterior region (Classes I and II)
    • Veneering of discolored anterior teeth .
    • Splinting of mobile teeth
    • Preventitive resin restorations in molars and premolars
    • Repair of composite and ceramic veneers
    • Inlays/Onlays with extra-oral post-tempering.
    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA for a dental material called "4 Seasons®". This document is a regulatory approval letter and does not contain the specific details of a study with acceptance criteria and reported device performance of an AI/ML powered medical device.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies, as these details are not present in the provided text. The document primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than a detailed performance study of the device itself.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1