LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K992728
    Device Name
    SPRING POWERLITE 2000
    Manufacturer
    SPRING HEALTH PRODUCTS, INC.
    Date Cleared
    1999-09-29

    (47 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

    High Intensity light for polymerization of dental materials and tooth whitening.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but this document is a 510(k) clearance letter from the FDA for a device called "Spring PowerLite 2000." It primarily states that the device has been found substantially equivalent to existing devices and can be marketed.

    However, the provided text does not contain any information regarding the acceptance criteria, the study details (like sample sizes, data provenance, expert qualifications, adjudication methods), multi-reader multi-case studies, standalone performance, or training set information.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided input.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1