Device Classification Name |
bone grafting material, animal source
|
510(k) Number |
K090794 |
Device Name |
OSTEOTAPE |
Applicant |
IMPLADENT, LTD. |
198-45 FOOTHILL AVE. |
HOLLISWOOD,
NY
11423
|
|
Applicant Contact |
MAURICE VALEN |
Correspondent |
IMPLADENT, LTD. |
198-45 FOOTHILL AVE. |
HOLLISWOOD,
NY
11423
|
|
Correspondent Contact |
MAURICE VALEN |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 03/24/2009 |
Decision Date | 12/10/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|