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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cord, Retraction
510(k) Number K171577
Device Name Smartcord, Smartcord X
Applicant
Eastdent Co., Ltd.
601-1 Sogong B/D, 64 Gugal-Ro, Giheung-Gu
Yongin-Si,  KR 16972
Applicant Contact Hyonsu Kim
Correspondent
Eastdent Co., Ltd.
601-1 Sogong B/D, 64 Gugal-Ro, Giheung-Gu
Yongin-Si,  KR 16972
Correspondent Contact Hyonsu Kim
Classification Product Code
MVL  
Date Received05/30/2017
Decision Date 05/03/2018
Decision Substantially Equivalent (SESE)
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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