Brux Night Guard

• K Number: K181361
• Device Name: Brux Night Guard
• Manufacturer: Brux Night Guard
• Date Cleared: 2019-04-11 ( 323 days)
• Product Code: MQC
• Regulation Number: N/A
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Brux Night Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria, device performance, or any studies conducted for the Brux Night Guard. The document is an FDA 510(k) clearance letter confirming that the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory information and indications for use, but no performance data or study details.

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

Regulation Number and Section

N/A