LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K143655
    Device Name
    SICAT OPTIMOTION
    Manufacturer
    SICAT GMBH & CO. KG
    Date Cleared
    2015-10-02

    (283 days)

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

    SICAT OPTIMOTION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Protection of teeth and restorations from injury due to bruxism.
    • Temporary relief of Temporal Mandibular Disorder (TMD) and bruxism by reducing muscle tension.
    • Temporary treatment of Temporal Mandibular Disorder (TMD) along with the relief of associated headaches and pains.
    Device Description

    Not Found

    AI/ML Overview

    The provided documents do not contain information about the acceptance criteria, reported device performance, or the details of a study proving the device meets acceptance criteria. The documents are a 510(k) clearance letter from the FDA for the SICAT OPTIMOTION device and its Indications for Use.

    The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

    This indicates that the FDA's decision was based on a determination of substantial equivalence to a predicate device, rather than a direct evaluation against specific acceptance criteria presented in a study within this submission.

    Therefore, I cannot provide the requested information from the given text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1