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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 K213599
Device Name SuperLine
Applicant
Dentium Co., Ltd.
76, Changnyong-daero 256beon-gil
Suwon-si,  KR 16229
Applicant Contact Eunsang Lee
Correspondent
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego,  CA  92130
Correspondent Contact Kevin A Thomas
Regulation Number872.3640
Classification Product Code
DZE  
Date Received11/15/2021
Decision Date 02/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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