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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 K083400
Device Name CUSTOM COMFORT NIGHTGUARD
Applicant
Den Tek Oral Care, Inc.
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Den Tek Oral Care, Inc.
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN
Classification Product Code
OBR  
Date Received11/17/2008
Decision Date 12/11/2008
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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