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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aligner, Sequential
510(k) Number K143499
FOIA Releasable 510(k) K143499
Device Name eCligner
Applicant
Eclear International Co., Ltd.
30 Teheranro 27 Gil, Gangnam-Gu
Seoul,  KR 135-915
Applicant Contact Tae Weon Kim
Correspondent
Withus Consulting
2531 Pepperdale Dr.
Rowland Heights,  CA  91748
Correspondent Contact April Lee
Regulation Number872.5470
Classification Product Code
NXC  
Date Received12/10/2014
Decision Date 10/09/2015
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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