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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 K183315
Device Name CustMBite Dental Guard
Applicant
Dental Choice Holdings, LLC
10100 Linn Station Road
Louisville,  KY  40223
Applicant Contact Ron Story
Correspondent
Smith Associates
1468 Harwell Avenue
Crofton,  MD  21114
Correspondent Contact E.J. Smith
Classification Product Code
OBR  
Date Received11/30/2018
Decision Date 08/23/2019
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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