LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K102739
    Device Name
    HYDROCOLOR 5
    Manufacturer
    CASCADES DEVICE CONSULTING ASSOCIATES
    Date Cleared
    2010-12-08

    (77 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    HYDROCOLOR 5 is a conventional alginate dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth. It is also intended to provide models for study and for the production of restorative prosthetic devices, such as dental inlays and dentures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance for the HYDROCOLOR 5 impression material. The text is a 510(k) clearance letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory requirements and indications for use but does not include details on specific performance criteria or a study to demonstrate them.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1