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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 K102308
Device Name SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS
Applicant
Dentium Co., Ltd.
6761 Katella Ave.
Cypress,  CA  90630
Applicant Contact EUNKYUNG SON
Correspondent
Dentium Co., Ltd.
6761 Katella Ave.
Cypress,  CA  90630
Correspondent Contact EUNKYUNG SON
Regulation Number872.3640
Classification Product Code
DZE  
Date Received08/16/2010
Decision Date 11/22/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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