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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 K150141
Device Name Orthodontics Bracket
Applicant
Speed Dental Co., Ltd.
#203-1, A-Dong, Posco The Sharp, 151 Sunhwa-Dong, Jung-Gu
Seoul,  KR 100-130
Applicant Contact Tae Young Kang
Correspondent
Onbix Corporation
#821 Samil Plz., 837 -26 Yeuksam-Dong
Gangnam-Gu,  KR 135-768
Correspondent Contact Ho Dong Yang
Regulation Number872.5470
Classification Product Code
NJM  
Date Received01/22/2015
Decision Date 10/23/2015
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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