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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anti-Snoring
510(k) Number K261134
Device Name Dormiva Anti-Snoring Mouth Guard
Applicant
Koncept Innovators, Inc.
1619 Executive Ave.
Myrtle Beach,  SC  29577
Applicant Contact Maureen Garner
Correspondent
Newworld Regulatory Solutions, Inc.
11700 W. Charleston Blvd. Suite 170-390
Las Vegas,  NV  89135
Correspondent Contact Maureen Garner
Regulation Number872.5570
Classification Product Code
LRK  
Subsequent Product Code
LQZ  
Date Received04/07/2026
Decision Date 05/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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