LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K023652
    Device Name
    REMECURE MODEL CL 15E
    Manufacturer
    REMEDENT NV
    Date Cleared
    2003-01-09

    (71 days)

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

    REMECURE MODEL CL 15E

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

    The Remecure CL-15E produces visible light for the polymerization of dental materials and for tooth whitening.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for the Remecure CL-15E device, which is an Ultraviolet Activator for Polymerization.

    This type of document primarily confirms that the device is substantially equivalent to a legally marketed predicate device and can therefore be marketed. While it details the device name, regulation number, and indications for use, it does not include:

    • A table of acceptance criteria or reported device performance.
    • Details about any specific study (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for test or training sets).

    The FDA's substantial equivalence determination for 510(k) devices often relies on comparisons to predicate devices that have already demonstrated safety and effectiveness, rather than requiring extensive new clinical trial data that would outline such detailed study parameters.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1