Device Classification Name |
Material, Impression
|
510(k) Number |
K073005 |
Device Name |
ELITE GLASS |
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 | 10/24/2007 |
Decision Date | 12/12/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|