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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 K171126
Device Name Implantium II
Applicant
Dentium Co., Ltd.
150, Eondong-Ro
Giheung-Gu
Yongin-Si,  KR 443-270
Applicant Contact Yoon Spyoon
Correspondent
Denterprise International, Inc. / 510k FDA Consulting
100 E. Granada Bldv,
Suite 219
Ormond Beach,  FL  32176
Correspondent Contact Joyce St. Germain
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/17/2017
Decision Date 09/07/2017
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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