Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K053099 |
Device Name |
BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS |
Applicant |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
ONE PERIMETER PARK SOUTH |
SUITE 230, SOUTH |
BIRMINGHAM,
AL
35243
|
|
Applicant Contact |
WINSTON GREER |
Correspondent |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
ONE PERIMETER PARK SOUTH |
SUITE 230, SOUTH |
BIRMINGHAM,
AL
35243
|
|
Correspondent Contact |
WINSTON GREER |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 11/03/2005 |
Decision Date | 02/14/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|