Bright Guard

Mouthguard, Over-the-counter

Koncept Innovators, LLC.

The following data is part of a premarket notification filed by Koncept Innovators, Llc. with the FDA for Bright Guard.

Pre-market Notification Details

• Device ID: K181099
• 510k Number: K181099
• Device Name: Bright Guard
• Classification: Mouthguard, Over-the-counter
• Applicant: Koncept Innovators, LLC. 1619 Executive Ave Myrtle Beach, SC 29577
• Contact: Sylvan Newby
• Correspondent: Maureen Garner; New World Regulatory Solutions, Inc. 11700 W. Charleston Boulevard Suite 170-390 Las Vegas, NV 89135
• Product Code: OBR
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-04-26
• Decision Date: 2019-01-18
• Summary: summary