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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 K141104
FOIA Releasable 510(k) K141104
Device Name TRUKLEAR BRACKET
Applicant
Ajw Technology Consultants, Inc.
445 Apollo Beach Blvd.
Apollo Beach,  FL  33572
Applicant Contact TANYA O'BRIEN
Correspondent
Ajw Technology Consultants, Inc.
445 Apollo Beach Blvd.
Apollo Beach,  FL  33572
Correspondent Contact TANYA O'BRIEN
Regulation Number872.5470
Classification Product Code
NJM  
Date Received04/29/2014
Decision Date 06/25/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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