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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 K152167
Device Name BIJOU Orthodontic Ceramic Bracket
Applicant
World Bio Tech Co., Ltd.
#302 Bizcenter, Skntechnopark, 124, Sagimakgol-Ro,
Jungwon-Gu
Seongnam-Si,  KR 462-721
Applicant Contact JIN-KYU PARK
Correspondent
Plusglobal
300, Atwood
Pittsburgh,  PA  15213
Correspondent Contact PETER CHUNG
Regulation Number872.5470
Classification Product Code
NJM  
Date Received08/04/2015
Decision Date 05/27/2016
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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