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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
PLUS GLOBAL
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
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