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
|
|
Correspondent Contact |
WINSTON GREER |
Regulation Number | 872.3640
|
Classification Product Code |
|
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
|
Recalls |
CDRH Recalls
|
|
|