LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K153018
    Device Name
    CELALUX 3
    Manufacturer
    VOCO GMBH
    Date Cleared
    2016-06-23

    (252 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 Celalux 3 curing light is indicated for polymerization of dental materials which cure with blue light (450 nm to 480 nm).

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for the Celalux 3, a dental curing light. It confirms that the device is substantially equivalent to a predicate device for its indicated use (polymerization of dental materials with blue light).

    However, this document does not contain any information regarding the acceptance criteria, device performance study, sample sizes, expert qualifications, ground truth establishment, or any other details related to the evaluation of an AI/ML medical device. It is a regulatory clearance for a physical medical device (a light curing unit), not an AI algorithm.

    Therefore, I cannot fulfill your request using the provided input, as the information you are asking for (related to AI acceptance criteria and study details) is not present in this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1