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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 K151933
Device Name BRX PRO Bruxism Guard
Applicant
12th Man Technologies, Inc.
7245 Garden Grove Blvd.,
Suite C
Garden Grove,  CA  92841
Applicant Contact ALEX STENZLER
Correspondent
12th Man Technologies, Inc.
7245 Garden Grove Blvd.,
Suite C
Garden Grove,  CA  92841
Correspondent Contact ALEX STENZLER
Classification Product Code
MQC  
Date Received07/14/2015
Decision Date 12/10/2015
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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