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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 K252485
Device Name ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))
Applicant
1987 Media Limited
Alfa House
Molesey Rd.
Walton-On-Thames,  GB KT123PD
Applicant Contact Thomas Hartnett
Correspondent
MD Compliance Limited
234 W. George St.
Glasgow,  GB G24QY
Correspondent Contact Andrew Donn
Classification Product Code
OBR  
Date Received08/07/2025
Decision Date 04/10/2026
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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