Device Classification Name |
Implant, Endosseous, Root-Form
|
510(k) Number |
K050258 |
Device Name |
GROOVY IMPLANTS |
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 | 02/03/2005 |
Decision Date | 04/19/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|