Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K081818 |
Device Name |
BIOLOK MICRO-LOK IMPLANT SYSTEM |
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
|
|
Correspondent Contact |
MICHAEL DAVIS |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 06/27/2008 |
Decision Date | 11/13/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|