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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 K091660
Device Name CUSTOM COMFORT NIGHTGUARD VERSION 2
Applicant
DENTEK ORAL CARE, INC.
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Applicant Contact HOWARD M HOLSTEIN
Correspondent
DENTEK ORAL CARE, INC.
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN
Classification Product Code
OBR  
Date Received06/09/2009
Decision Date 06/12/2009
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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