Device Classification Name |
bone grafting material, synthetic
|
510(k) Number |
K053374 |
Device Name |
OSSAPLAST DENTAL (PARTICLE SIZE OF 500 TO 1000 UM TO 2000 UM) |
Applicant |
OSSACUR AG |
975 VERONICS SPRINGS ROAD |
SANTA BARBARA,
CA
93105
|
|
Applicant Contact |
KRISTI KISTNER |
Correspondent |
OSSACUR AG |
975 VERONICS SPRINGS ROAD |
SANTA BARBARA,
CA
93105
|
|
Correspondent Contact |
KRISTI KISTNER |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 12/05/2005 |
Decision Date | 02/21/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|