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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 K262421
Device Name Daybreak Impression Material
Applicant
Sleepcare, LLC
11858 La Grange Ave. Floor 2
Los Angeles,  CA  90025
Applicant Contact Eliane Schaefer
Correspondent
Sleepcare, LLC
11858 La Grange Ave. Floor 2
Los Angeles,  CA  90025
Correspondent Contact Eliane Schaefer
Regulation Number872.3660
Classification Product Code
SHI  
Date Received07/16/2026
Decision Date 10/20/2026
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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