| Device Classification Name |
Material, Tooth Shade, Resin
|
| 510(k) Number |
K031341 |
| Device Name |
STICK FLOW |
| Applicant |
| Stick Tech , Ltd. |
| 80 Pkwy. W. |
|
Mount Vernon,
NY
10552
|
|
| Applicant Contact |
WILLIAM TROETEL |
| Correspondent |
| Stick Tech , Ltd. |
| 80 Pkwy. W. |
|
Mount Vernon,
NY
10552
|
|
| Correspondent Contact |
WILLIAM TROETEL |
| Regulation Number | 872.3690 |
| Classification Product Code |
|
| Date Received | 04/28/2003 |
| Decision Date | 10/29/2003 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Dental
|
| 510k Review Panel |
Dental
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|