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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 K073268
Device Name BIOHORIZONS INTERNAL IMPLANT SYSTEM
Applicant
BioHorizons Implant Systems, Inc.
2300 Riverchase Center
Birmingham,  AL  35244
Applicant Contact WINSTON GREER
Correspondent
BioHorizons Implant Systems, Inc.
2300 Riverchase Center
Birmingham,  AL  35244
Correspondent Contact WINSTON GREER
Regulation Number872.3640
Classification Product Code
DZE  
Date Received11/20/2007
Decision Date 02/08/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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