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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 K072147
Device Name DEN TEK COMFORT FIT NIGHTGUARD
Applicant
Den Tek Oral Care, Inc.
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact HOWARD HOLSTEIN, ESQ.
Correspondent
Den Tek Oral Care, Inc.
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact HOWARD HOLSTEIN, ESQ.
Classification Product Code
OBR  
Date Received08/03/2007
Decision Date 08/30/2007
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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