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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 K252004
Device Name enCore Night Guard
Applicant
Encore Guards
1520 Brookhollow Dr.
Unit 38
Santa Ana,  CA  92705
Applicant Contact Benjamin Li
Correspondent
Encore Guards
1520 Brookhollow Dr.
Unit 38
Santa Ana,  CA  92705
Correspondent Contact Benjamin Li
Classification Product Code
OBR  
Date Received06/27/2025
Decision Date 11/25/2025
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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