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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 K053099
Device Name BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS
Applicant
BIOHORIZONS IMPLANT SYSTEMS, INC.
ONE PERIMETER PARK SOUTH
SUITE 230, SOUTH
BIRMINGHAM,  AL  35243
Applicant Contact WINSTON GREER
Correspondent
BIOHORIZONS IMPLANT SYSTEMS, INC.
ONE PERIMETER PARK SOUTH
SUITE 230, SOUTH
BIRMINGHAM,  AL  35243
Correspondent Contact WINSTON GREER
Regulation Number872.3630
Classification Product Code
NHA  
Date Received11/03/2005
Decision Date 02/14/2006
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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