BIOHORIZONS ABUTMENTS FOR ZIMMER


Device Classification Name

abutment, implant, dental, endosseous

510(k) Number K103691
Device Name BIOHORIZONS ABUTMENTS FOR ZIMMER
Applicant
BIOHORIZONS IMPLANT SYSTEMS, INC.
2300 riverchase center
birmingham, 
AL 
35244

Applicant Contact michael davis
Correspondent
BIOHORIZONS IMPLANT SYSTEMS, INC.
2300 riverchase center
birmingham, 
AL 
35244

Correspodent Contact michael davis
Regulation Number 872.3630
Classification Product Code
NHA  
Date Received 12/17/2010
Decision Date 11/03/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No