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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name bracket, ceramic, orthodontic
510(k) Number K113334
Device Name AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS
Original Applicant
OPAL ORTHODONTICS BY ULTRADENT PRODUCTS INC.
10200 south 505 west
south jordan,  UT  84095
Original Contact diane rogers
Regulation Number872.5470
Classification Product Code
NJM  
Date Received11/14/2011
Decision Date 02/03/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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