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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthguard, Over-The-Counter
510(k) Number K181099
Device Name Bright Guard
Applicant
Koncept Innovators, LLC.
1619 Executive Ave
Myrtle Beach,  SC  29577
Applicant Contact Sylvan Newby
Correspondent
New World Regulatory Solutions, Inc.
11700 W. Charleston Boulevard Suite 170-390
Las Vegas,  NV  89135
Correspondent Contact Maureen Garner
Classification Product Code
OBR  
Date Received04/26/2018
Decision Date 01/18/2019
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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