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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 K251778
Device Name Remi Custom Night Guard
Applicant
Remi
155 Jackson St.
1206
San Francisco,  CA  94111
Applicant Contact Oscar Adelman
Correspondent
Prime Path Medtech
1321 Upland Dr.
Suite 6792
Houston,  TX  77043
Correspondent Contact Jennifer Day
Classification Product Code
OBR  
Subsequent Product Code
OCO  
Date Received06/10/2025
Decision Date 10/17/2025
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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