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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
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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