NTI ClenchGuard

Mouthguard, Over-the-counter

Boyd Research, Inc.

The following data is part of a premarket notification filed by Boyd Research, Inc. with the FDA for Nti Clenchguard.

Pre-market Notification Details

• Device ID: K211158
• 510k Number: K211158
• Device Name: NTI ClenchGuard
• Classification: Mouthguard, Over-the-counter
• Applicant: Boyd Research, Inc. 5820 Bali Way S St. Pete Beach, FL 33706
• Contact: James Boyd
• Correspondent: James Boyd; Boyd Research, Inc. 5820 Bali Way S St. Pete Beach, FL 33706
• Product Code: OBR
• Subsequent Product Code: MQC
• Subsequent Product Code: OCO
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-04-19
• Decision Date: 2021-09-17