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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K141457
Device Name DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS
Applicant
Dentium Co., Ltd.
6761 Katella Ave.
Cypress,  CA  90630
Applicant Contact SHERYL HIGGINS
Correspondent
Dentium Co., Ltd.
6761 Katella Ave.
Cypress,  CA  90630
Correspondent Contact SHERYL HIGGINS
Regulation Number872.3630
Classification Product Code
NHA  
Date Received06/02/2014
Decision Date 11/12/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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