Device Classification Name |
material, impression
|
510(k) Number |
K050417 |
Device Name |
ELITE IMPLANT |
Applicant |
ZHERMACK S.P.A. |
19379 BLUE LAKE LOOP |
BEND,
OR
97702
|
|
Applicant Contact |
GERALD W SHIPPS |
Correspondent |
ZHERMACK S.P.A. |
19379 BLUE LAKE LOOP |
BEND,
OR
97702
|
|
Correspondent Contact |
GERALD W SHIPPS |
Regulation Number | 872.3660
|
Classification Product Code |
|
Date Received | 02/18/2005 |
Decision Date | 07/19/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|