Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K063718 |
Device Name |
SFB AND CFB IMPLANTS - 5.0 PLATFORM |
Applicant |
NOBEL BIOCARE AB |
22715 SAVI RANCH PKWY. |
YORBA LINDA,
CA
92887
|
|
Applicant Contact |
HERBERT CRANE |
Correspondent |
NOBEL BIOCARE AB |
22715 SAVI RANCH PKWY. |
YORBA LINDA,
CA
92887
|
|
Correspondent Contact |
HERBERT CRANE |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 12/14/2006 |
Decision Date | 01/05/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|