LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K971138
    Device Name
    DINABASE (TM)
    Manufacturer
    SULTAN CHEMISTS, INC.
    Date Cleared
    1997-07-21

    (115 days)

    Product Code
    EBI,DAT
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DINABASE (TM)

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

    Intended to reline a denture surface that contacts tissue--for temporary or provisional usage. Not for OTC use.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or details of a study that proves a device meets acceptance criteria. The document is a 510(k) premarket notification approval letter for a dental device called "Dinabase™", indicating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It also includes the intended use of the device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the given information.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1