Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K050641 |
Device Name |
ZYGOMA TIUNITE |
Applicant |
NOBEL BIOCARE USA LLC |
22715 SAVI RANCH PARKWAY |
YORBA LINDA,
CA
92887
|
|
Applicant Contact |
ELIZABETH MASON |
Correspondent |
NOBEL BIOCARE USA LLC |
22715 SAVI RANCH PARKWAY |
YORBA LINDA,
CA
92887
|
|
Correspondent Contact |
ELIZABETH MASON |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 03/14/2005 |
Decision Date | 04/07/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|