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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 K222792
Device Name SNUCONE Tissue Level Implant System
Applicant
Snucone Co., Ltd.
5, Seongseo-Ro 75-Gil
Dalseo-Gu,  KR 42703
Applicant Contact Song Ha Eun
Correspondent
Wise Company, Inc.
#507, #508, 166 Gasan Digital 2-Ro
Geumcheon-Gu,  KR 08507
Correspondent Contact Sanglok Lee
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received09/16/2022
Decision Date 06/08/2023
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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