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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 K053580
Device Name DOCTOR'S NIGHTGUARD
Applicant
DENTAL CONCEPTS LLC.
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Applicant Contact HOWARD M HOLSTEIN
Correspondent
DENTAL CONCEPTS LLC.
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN
Classification Product Code
MQC  
Date Received12/22/2005
Decision Date 03/03/2006
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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