LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K030811
    Device Name
    COOL CURE
    Manufacturer
    SAMM, INC.
    Date Cleared
    2003-06-10

    (89 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The dialal curing light and accessories, Cool Cure, is used to provide a source of illumination for curing dental restorative matcrials in the mouth.

    Device Description

    Cool Cure, Dental Curing Light and Accessories

    AI/ML Overview

    I am sorry, but based on the text provided, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a dental curing light, and it does not contain the detailed information about acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications that you are asking for.

    The document primarily focuses on establishing "substantial equivalence" to a predicate device, which is a regulatory pathway, not a detailed scientific study report demonstrating performance against specific acceptance criteria.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1