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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
Predetermined Change
Control Plan Authorized		 No
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