Device Classification Name |
bone grafting material, synthetic
|
510(k) Number |
K121177 |
Device Name |
BOND APATITE |
Applicant |
AUGMA BIOMATERIALS, LTD. |
11234 EL CAMINO REAL |
SUITE 200 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
KEVIN A THOMAS |
Correspondent |
AUGMA BIOMATERIALS, LTD. |
11234 EL CAMINO REAL |
SUITE 200 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
KEVIN A THOMAS |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 04/18/2012 |
Decision Date | 12/05/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|