LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K092020
    Device Name
    AADVA ZR COLORING LIQUID
    Manufacturer
    GC AMERICA INC.
    Date Cleared
    2009-09-29

    (85 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K022996,K011394
    Why did this record match?
    Device Name :

    AADVA ZR COLORING LIQUID

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

    Aadva Zr Coloring Liquid is a liquid used for the complete or partial coloration of milled porcelain substructures before sintering.

    Device Description

    Aadva Zr Coloring Liquid is a liquid used for the complete or partial coloration of milled substructures before sintering. Aadva Zr Coloring Liquid is available in 8 shades.

    AI/ML Overview

    The provided text is a 510(k) summary for a dental device (Aadva Zr Coloring Liquid) and its FDA clearance letter. It does not contain information about acceptance criteria, device performance metrics, or any studies involving human readers, training sets, or ground truth establishment.

    This document focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than a detailed performance study as would be seen for AI/ML-based medical devices.

    Therefore, I cannot provide the requested information from this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1