Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K063592 |
Device Name |
ADAPTER PS RP-NP, 34551, ADAPTER PS WP-RP,34552, ABUTMENT SCREW PS RP-NP, 34553, ABUTMENT SCREW PS WP-RP, 34554 |
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 | 872.3630
|
Classification Product Code |
|
Date Received | 12/04/2006 |
Decision Date | 02/27/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|