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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 K120471
Device Name MACH BRACKETS BRIGHT BRACKETS
Applicant
World Bio Tech Co., Ltd.
300, Atwood
Pittsburgh,  PA  15213
Applicant Contact PETER CHUNG
Correspondent
World Bio Tech Co., Ltd.
300, Atwood
Pittsburgh,  PA  15213
Correspondent Contact PETER CHUNG
Regulation Number872.5470
Classification Product Code
NJM  
Date Received02/16/2012
Decision Date 06/04/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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