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 |