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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 K081786
Device Name ZIOCERA & CONVERTIBLE SYSTEM
Applicant
OSSTEM IMPLANT CO LTD
85 BEN FAIRLESS DR.
FAIRLESS HILLS,  PA  19030
Applicant Contact MINJOO KIM
Correspondent
OSSTEM IMPLANT CO LTD
85 BEN FAIRLESS DR.
FAIRLESS HILLS,  PA  19030
Correspondent Contact MINJOO KIM
Regulation Number872.3630
Classification Product Code
NHA  
Date Received06/24/2008
Decision Date 12/02/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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