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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K192294
Device Name I Do
Applicant
I DO Biotech Co., Ltd.
#C, 135, Seongseodong-Ro, Dalsoe-Gu
Daegu,  KR 42721
Applicant Contact Jae-Hyung Song
Correspondent
Withus Group, Inc.
106 Superior
Irvine,  CA  92620
Correspondent Contact April Lee
Regulation Number872.3640
Classification Product Code
DZE  
Date Received08/23/2019
Decision Date 07/31/2020
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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