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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 K123849
Device Name NEW COMFORT-FIT DENTAL GUARD
Applicant
Den Tek Oral Care, Inc.
307 Excellence Way
Maryville,  TN  37801
Applicant Contact LINDA GILES
Correspondent
Den Tek Oral Care, Inc.
307 Excellence Way
Maryville,  TN  37801
Correspondent Contact LINDA GILES
Classification Product Code
OBR  
Date Received12/14/2012
Decision Date 01/10/2013
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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