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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 K221369
Device Name FBCC Night Guard
Applicant
Fbcc, Inc.
6711 S Sepulveda Blvd., Unit 602
Los Angeles,  CA  90045
Applicant Contact Pablo Osorio
Correspondent
Prime Path Medtech
1321 Upland Dr.
Suite 6792
Houston,  TX  77043
Correspondent Contact Elisabeth Miller
Classification Product Code
OBR  
Date Received05/12/2022
Decision Date 11/18/2022
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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