| Device Classification Name |
Alloy, Metal, Base
|
| 510(k) Number |
K040179 |
| Device Name |
CONTINUM |
| Applicant |
| Aalba Dent, Inc. |
| 400 Watt Dr. |
|
Fairfield,
CA
94534
|
|
| Applicant Contact |
VINCENT M BENETTI |
| Correspondent |
| Aalba Dent, Inc. |
| 400 Watt Dr. |
|
Fairfield,
CA
94534
|
|
| Correspondent Contact |
VINCENT M BENETTI |
| Regulation Number | 872.3710 |
| Classification Product Code |
|
| Date Received | 01/27/2004 |
| Decision Date | 03/03/2004 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Dental
|
| 510k Review Panel |
Dental
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|