Device Classification Name |
Bone Grafting Material, Synthetic
|
510(k) Number |
K071817 |
Device Name |
OSTEOGRAF/N-300 |
Applicant |
DENTSPLY INTERNTIONAL |
221 W. PHILADELPHIA ST. STE.60 |
SUSQUEHANNA COMMERCE CRT. WEST |
YORK,
PA
17404
|
|
Applicant Contact |
HELEN LEWIS |
Correspondent |
DENTSPLY INTERNTIONAL |
221 W. PHILADELPHIA ST. STE.60 |
SUSQUEHANNA COMMERCE CRT. WEST |
YORK,
PA
17404
|
|
Correspondent Contact |
HELEN LEWIS |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 07/03/2007 |
Decision Date | 09/04/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|