Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K100985 |
Device Name |
BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK |
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 | 872.3630
|
Classification Product Code |
|
Date Received | 04/09/2010 |
Decision Date | 09/09/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|