LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K102612
    Device Name
    VOCO IONOFIL MOLAR AC QUICK
    Manufacturer
    VOCO GMBH
    Date Cleared
    2010-11-19

    (70 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    VOCO lonofil Molar AC Quick is intended for the following applications:

    • restoration of V-shaped defects and cervical enamel or root erosions including class V cavities
    • restoration of deciduous teeth (especially class I)
    • fillings of class II cavities (non-occlusion-bearing) by means of tunnel preparations
    • build-up fillings and linings, core build-up
    • temporary long-term treatment of class I and II cavities
    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a dental cement product, "VOCO Ionofil Molar AC Quick." This type of document primarily confirms that a new device is substantially equivalent to a legally marketed predicate device, and it outlines regulatory obligations.

    It does NOT contain information about specific acceptance criteria for device performance, nor does it describe clinical studies proving a device meets such criteria.

    Therefore, I cannot provide the requested information based on this document. The document's purpose is regulatory clearance, not the presentation of performance study results.

    To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (SSED), a clinical study report, or a detailed technical submission for the device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1