| Device Classification Name |
material, impression |
|||
|---|---|---|---|---|
| 510(k) Number | K081120 | |||
| Device Name | FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS | |||
| Applicant |
|
|||
| Applicant Contact | michaela zinke | |||
| Regulation Number | 872.3660 | |||
| Classification Product Code |
|
|||
| Date Received | 04/21/2008 | |||
| Decision Date | 05/01/2008 | |||
| Decision |
substantially equivalent (SESE) |
|||
| Regulation Medical Specialty |
Dental |
|||
| 510k Review Panel |
Dental |
|||
| summary |
summary |
|||
| Type | Traditional | |||
| Reviewed by Third Party | Yes | |||
| Combination Product |
No |