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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 K163467
Device Name C-Line Orthodontic Ceramic Bracket
Applicant
BIOCETEC CO., LTD
RM 3-952AB, H1-DONG, KIST,5, HWARANG-RO 14-GIL
(HAWOLGOK-DONG 39-1)
SEOUL,  KR
Applicant Contact DAVE KIM
Correspondent
MTECH GROUP
8310 BUFFALO SPEEDWAY
HOUSTON,  TX  77025
Correspondent Contact DAVE KIM
Regulation Number872.5470
Classification Product Code
NJM  
Date Received12/12/2016
Decision Date 06/14/2017
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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