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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 K061567
Device Name BIOHORIZONS CERAMIC ABUTMENT
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 Received06/06/2006
Decision Date 11/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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