LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K162654

    Validate with FDA (Live)

    Device Name
    mollosil plus
    Manufacturer
    DETAX GmbH & Co.KG
    Date Cleared
    2017-03-13

    (171 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Used for fabricating long-term soft denture relinings by direct or indirect application.

    Device Description

    Not Found

    AI/ML Overview

    This FDA document is a clearance letter for a dental device, "Mollosil Plus," classifying it as substantially equivalent to existing predicate devices. It does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

    Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory approval, not a performance study report.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1