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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 K081818
Device Name BIOLOK MICRO-LOK IMPLANT SYSTEM
Applicant
BIOHORIZONS IMPLANT SYSTEMS, INC.
2300 RIVERCHASE CENTER
BIRMINGHAM,  AL  35244
Applicant Contact MICHAEL DAVIS
Correspondent
BIOHORIZONS IMPLANT SYSTEMS, INC.
2300 RIVERCHASE CENTER
BIRMINGHAM,  AL  35244
Correspondent Contact MICHAEL DAVIS
Regulation Number872.3640
Classification Product Code
DZE  
Date Received06/27/2008
Decision Date 11/13/2008
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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