LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K030641
    Device Name
    CONTEC LIGHT
    Manufacturer
    DENTAURUM
    Date Cleared
    2003-06-10

    (102 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CONTEC LIGHT

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

    ConTec Light is used to set resinous dental adhesive material by transmission of visible light.

    Device Description

    Not Found

    AI/ML Overview

    This request cannot be fulfilled. The document provided is an FDA 510(k) clearance letter for a dental light curing device called "ConTec Light". It confirms substantial equivalence to a predicate device and allows the manufacturer to market it.

    However, the document does NOT contain any information regarding:

    • Acceptance criteria table or reported device performance metrics (e.g., accuracy, sensitivity, specificity).
    • Any details about a study that proves the device meets specific performance criteria.
    • Sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set details.

    The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive performance studies with detailed statistical analyses as might be found in a PMA (Premarket Approval) submission for a novel, high-risk device, or a publication describing a clinical trial for an AI-powered diagnostic.

    Therefore, I cannot extract the requested information from the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1