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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter
510(k) Number K251926
Device Name enCore Impression Material
Applicant
Encore Guards
1520 Brookhollow Dr.
Suite 38
Santa Ana,  CA  92705
Applicant Contact Benjamin Li
Correspondent
Encore Guards
1520 Brookhollow Dr.
Suite 38
Santa Ana,  CA  92705
Correspondent Contact Benjamin Li
Regulation Number872.3660
Classification Product Code
SHI  
Date Received06/23/2025
Decision Date 03/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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