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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 K151149
Device Name Ready-Fit
Applicant
Den Tek Oral Care, Inc.
397 Excellence Way
Maryville,  TN  37801
Applicant Contact LINDA GILES
Correspondent
Den Tek Oral Care, Inc.
397 Excellence Way
Maryville,  TN  37801
Correspondent Contact LINDA GILES
Classification Product Code
OBR  
Date Received04/30/2015
Decision Date 09/30/2015
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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