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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthguard, Prescription
510(k) Number K250743
Device Name Remvia NightGuard
Applicant
Remvia
911 Washington Ave.
#500
St. Louis,  MO  63101
Applicant Contact Nephi Zufelt
Correspondent
Remvia
911 Washington Ave.
#500
St. Louis,  MO  63101
Correspondent Contact Nephi Zufelt
Classification Product Code
MQC  
Subsequent Product Code
OCO  
Date Received03/11/2025
Decision Date 12/05/2025
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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