LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K991488
    Device Name
    SELF CURE COMPOSITE
    Manufacturer
    HARRY J. BOSWORTH CO.
    Date Cleared
    1999-06-21

    (54 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

    The two paste system, when combined in approximately equal portions of universal and catalyst, will auto-polymerize to form a hard, radiopaque material for anterior restorations and core buildups.

    Device Description

    SELF CURE COMPOSITE

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a dental product called "Self Cure Composite." This type of document does not typically contain acceptance criteria or a study description in the way that a software or AI/ML device submission would.

    The letter focuses on the FDA's determination of substantial equivalence to a previously marketed predicate device. This means the manufacturer demonstrated that their device performs as intended and is as safe and effective as a device already legally on the market. The FDA letter approves the device based on this comparison, rather than detailing specific performance metrics and a study that proves they are met.

    Therefore, I cannot extract the requested information (acceptance criteria, reported performance, sample sizes, ground truth establishment, etc.) from this document. The provided text is a regulatory approval document, not a scientific study report or performance evaluation.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1