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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 K261888
Device Name ClearClub Impression Material
Applicant
ClearClub
8915 S La Cienega Blvd.
Suite A
Inglewood,  CA  90301
Applicant Contact Pablo Osorio
Correspondent
ClearClub
8915 S La Cienega Blvd.
Suite A
Inglewood,  CA  90301
Correspondent Contact Pablo Osorio
Regulation Number872.3660
Classification Product Code
SHI  
Date Received06/05/2026
Decision Date 09/16/2026
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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