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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 K111310
Device Name BRUX MOUTHGUARDS
Applicant
DENTAL ARTE, INC.
7046 OWL'S NEST TERR
BRADERDON,  FL  34203
Applicant Contact CAROLYN PRIMUS
Correspondent
DENTAL ARTE, INC.
7046 OWL'S NEST TERR
BRADERDON,  FL  34203
Correspondent Contact CAROLYN PRIMUS
Classification Product Code
OBR  
Date Received05/10/2011
Decision Date 12/08/2011
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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