LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K121282
    Device Name
    MICROLUX/DL MICROLUX/BLU BIO/SCREEN
    Manufacturer
    ADDENT, INC.
    Date Cleared
    2012-07-24

    (85 days)

    Product Code
    NXV
    Regulation Number
    872.6350
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K041614,K072309,K082668
    Why did this record match?
    Device Name :

    MICROLUX/DL MICROLUX/BLU BIO/SCREEN

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

    The ORABLU Oral Lesion Marking System is a three component swab system intended to be used by a dentist as an adjunct to traditional oral examination by incandescent light, combined with further examination with one of three oral examination lights manufactured by AdDent, Inc. The Microlux DL (K041614), Microlux BLU (K072309), and Bio/Screen (K082668). The ORABLU Oral Lesion Marking System is used as an aid to enhance the visualization of oral mucosal irregularities by physically marking areas of oral mucosa that may warrant further investigation.

    Device Description

    The ORABLU Oral Lesion Marking System is a three component swab system.

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for the ORABLU Oral Lesion Marking System. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter confirms substantial equivalence to a predicate device and states that the device can be marketed.

    Therefore, I cannot provide the requested information based on the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1