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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 K253641
Device Name Owl Night Guard
Applicant
Owl Dental Lab, Inc.
345 Estudillo Ave.
211
San Leandro,  CA  94577
Applicant Contact Jason Huang
Correspondent
Prime Path Medtech
539 W. Commerce St. #5446
Dallas,  TX  75208
Correspondent Contact Jennifer Day
Classification Product Code
OBR  
Subsequent Product Codes
MQC   OCO  
Date Received11/19/2025
Decision Date 02/26/2026
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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