ClenchGuard

• K Number: K181005
• Device Name: ClenchGuard
• Manufacturer: Boyd Research, Inc.
• Date Cleared: 2020-01-15 ( 639 days)
• Product Code: OBR
• Regulation Number: N/A
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

• Protection against bruxism or nighttime teeth grinding.
• Reduce damage to the teeth and reduce the noise associated with bruxing and/or grinding.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text only contains an FDA clearance letter for a device called "ClenchGuard" and its indications for use. It primarily focuses on regulatory approval and does not include information about acceptance criteria, a study proving device performance, or any of the detailed technical and clinical study parameters you've requested (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance).

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

Regulation Number and Section

N/A