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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 K113326
Device Name ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD
Applicant
ORALABS, INC.
18685 EAST PLAZA DRIVE
PARKER,  CO  80134
Applicant Contact TERESA PURDUE
Correspondent
ORALABS, INC.
18685 EAST PLAZA DRIVE
PARKER,  CO  80134
Correspondent Contact TERESA PURDUE
Classification Product Code
OBR  
Date Received11/10/2011
Decision Date 06/27/2012
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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