BIOHORIZONS INTERNAL IMPLANT SYSTEM


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

Correspodent Contact winston greer
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 11/20/2007
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