Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K102436 |
Device Name |
NOBEL ACTIVE 3.0 |
Applicant |
NOBEL BIOCARE AB |
15 BOHUSGATAN, |
P.O. BOX 5190 |
GOTEBORG,
SE
S-402 26
|
|
Applicant Contact |
HERBERT CRANE |
Correspondent |
NOBEL BIOCARE AB |
15 BOHUSGATAN, |
P.O. BOX 5190 |
GOTEBORG,
SE
S-402 26
|
|
Correspondent Contact |
HERBERT CRANE |
Regulation Number | 872.3640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/26/2010 |
Decision Date | 12/09/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|