LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K980616
    Device Name
    PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15)
    Manufacturer
    KOHLER MEDIZINTECHNIK GMBH & CO. KG
    Date Cleared
    1998-04-30

    (71 days)

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

    PERMAFIX is intended to permanently reline a denture surface that contacts tissue.

    The product is self-curing and is intended for chairside use in dental practices and for dental laboratories. It is not intended for over-the-counter (OTC) use.

    Applications

    To avoid and to relieve pressure areas in the upper and lower denture

    Post-damming of the A-line

    Elastic cover for dentures in the upper jaw

    Cushioning of overdentures that contact implants during the process of healing in the field of implantology

    Device Description

    PERMAFIX - Chairside Soft Denture Relining Device. The reliner remains permanently soft. Material: A-Silicone.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for a dental relining material called "Permafix" and lists its intended use and physical characteristics. It does not include details about device performance metrics, sample sizes for testing, ground truth establishment, or any comparative effectiveness studies. Therefore, I cannot fulfill your request based on the given input.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1