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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 K053152
Device Name BIOHORIZONS SINGLE-STAGE IMPLANT
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 Number872.3640
Classification Product Code
DZE  
Date Received11/10/2005
Decision Date 12/02/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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