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510(k) Data Aggregation

    K Number
    K022627
    Device Name
    DSG RELAXER SPLINT
    Manufacturer
    SENTAGE CORPORATION D/B/A/ DENTAL SERVICES GROUP
    Date Cleared
    2003-03-18

    (223 days)

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

    DSG RELAXER SPLINT

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

    The DSG Relaxer Splint is an acrylic device to be used in the treatment of medically diagnosed migraine pain as well as migraine associated tension-type headaches and relieving bruxism and temporomandibular joint syndrome through the reduction of trigeminally innervated muscular activity.

    Device Description

    The DSG Relaxer Splint is an acrylic device.

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called the "DSG Relaxer Splint." This document primarily addresses the substantial equivalence of the device to pre-existing devices and regulatory compliance.

    The document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about ground truth establishment.

    Therefore, I cannot fulfill your request for that specific information based on the text provided.

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