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K Number
K974160
Device Name
BRUXTRAK MATERIAL
Manufacturer
BRUXCARE, L.L.C.
Date Cleared
1998-03-11

(126 days)

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

Brux Trak™ material is intended for construction of temporary occlusal splints.

When properly formed by a licensed dentist or lab technician and prescribed by a licensed dentist, the device is intended to do the following:

    1. Temporarily protect the teeth or dental work from damage due to teeth grinding
    1. Promote patient awareness of oro-myofacial habits, such as bruxism.
    1. Aid the dentist in locating occlusal areas of current wear
    1. Aid the dentist in evaluating and measuring the severity of a patient's current teeth grinding habits
    1. Aid the dentist in differentiating between historical tooth wear and current grinding activity. ..
    1. Provide a physical record of a patient's grinding activity for a certain time period.
Device Description

Brux Trak™ material is intended for construction of temporary occlusal splints.

AI/ML Overview

This document is a 510(k) clearance letter for the BruxTrak™ device, which is described as a material for the construction of temporary occlusal splints. The letter states that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain information about acceptance criteria, device performance studies, or details of a study's methodology as requested in your prompt.

Therefore, I cannot provide the requested information based only on the provided text. The document primarily focuses on the regulatory approval process and indications for use, not on specific performance data or study details.

To answer your request, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a detailed 510(k) summary that includes performance data.

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.