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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 K123161
Device Name SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE
Applicant
Smartguard, Inc.
601 Brickell Key Dr.
Suite 104
Miami,  FL  33131
Applicant Contact SHELLY GARG
Correspondent
Smartguard, Inc.
601 Brickell Key Dr.
Suite 104
Miami,  FL  33131
Correspondent Contact SHELLY GARG
Classification Product Code
MQC  
Subsequent Product Code
OBR  
Date Received10/09/2012
Decision Date 03/14/2013
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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