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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 K182193
Device Name S-Line
Applicant
Biocetec Co., Ltd.
Rm.1001-1002 New T Castle, 108, Gasan Digital 2-Ro
Geumcheon-Gu
Seoul,  KR 08506
Applicant Contact Hee See JIN
Correspondent
Mtechgroup
8310 Buffalo Speedway
Houston,  TX  77025
Correspondent Contact Dave Kim
Regulation Number872.5470
Classification Product Code
NJM  
Date Received08/14/2018
Decision Date 01/22/2019
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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