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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 K080129
Device Name SECURE IMPLANT SYSTEM (2.5/3.0MM)
Applicant
Dio Department Dsi, Inc.
3540 Wilshire Blvd. Suite
1104
Los Angeles,  CA  90010
Applicant Contact HYUNGICK KIM
Correspondent
Dio Department Dsi, Inc.
3540 Wilshire Blvd. Suite
1104
Los Angeles,  CA  90010
Correspondent Contact HYUNGICK KIM
Regulation Number872.3640
Classification Product Code
DZE  
Date Received01/17/2008
Decision Date 05/30/2008
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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