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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 K160965
Device Name SuperLine
Applicant
Dentium Co., Ltd.
29 Teheran-Ro, 87-Gzl
Gangnam-Gu
Seoul,  KR 446-518
Applicant Contact YOUNJUNG YUK
Correspondent
Denteprise International, Inc. / 510k FDA Consulting
100 E Granada Blvd.
Suite 219
Ormond Beach,  FL  32176
Correspondent Contact CLAUDE BERTHOIN
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/06/2016
Decision Date 01/13/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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