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510(k) Data Aggregation

    K Number
    K980840

    Validate with FDA (Live)

    Device Name
    LOKKI DT
    Manufacturer
    HILLARD W. WELCH
    Date Cleared
    1999-03-15

    (376 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Pulpotomy Filling material such as gutta percha or resin bakelite removal as adjunct treatment during root canal retreatment

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental laser (LOKKI DT Laser and Accessories). This document does not contain information about acceptance criteria, device performance results from a study, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot fulfill your request to describe these elements based on the given text.

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