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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthguard, Prescription
510(k) Number K063483
Device Name DEN TEK NIGHTGUARD
Applicant
Den Tek Oral Care, Inc.
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Applicant Contact Jeffrey Shapiro
Correspondent
Den Tek Oral Care, Inc.
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact Jeffrey Shapiro
Classification Product Code
MQC  
Date Received11/17/2006
Decision Date 01/23/2007
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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