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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 K071638
Device Name BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM
Applicant
Biohorizons Implant Systems, Inc.
11234 El Camino Real
Suite 200
San Diego,  CA  92130
Applicant Contact LINDA K SCHULZ
Correspondent
Biohorizons Implant Systems, Inc.
11234 El Camino Real
Suite 200
San Diego,  CA  92130
Correspondent Contact LINDA K SCHULZ
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received06/15/2007
Decision Date 10/10/2007
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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