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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 K252698
Device Name NightGuard Aire Max
Applicant
Nightguard Express, LLC
571 W. Main St.
Lewisville,  TX  75057
Applicant Contact Flavia Alonso
Correspondent
Nightguard Express, LLC
571 W. Main St.
Lewisville,  TX  75057
Correspondent Contact Flavia Alonso
Regulation Number872.5570
Classification Product Code
LRK  
Subsequent Product Code
LQZ  
Date Received08/27/2025
Decision Date 11/03/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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