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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 Plaza, 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
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