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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, STE. 200
san diego,  CA  92130
Applicant Contact linda k schulz
Correspondent
BIOHORIZONS IMPLANT SYSTEMS, INC.
11234 EL CAMINO REAL, STE. 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
Recalls CDRH Recalls
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