| Device Classification Name |
material, impression |
|||
|---|---|---|---|---|
| 510(k) Number | K131510 | |||
| Device Name | POLYDIMETHYLSILOXANE IMPRESSION MATERIAL | |||
| Applicant |
|
|||
| Applicant Contact | angela blackwell | |||
| Correspondent |
|
|||
| Correspodent Contact | angela blackwell | |||
| Regulation Number | 872.3660 | |||
| Classification Product Code |
|
|||
| Date Received | 05/24/2013 | |||
| Decision Date | 12/20/2013 | |||
| Decision |
substantially equivalent (SESE) |
|||
| Regulation Medical Specialty |
Dental |
|||
| 510k Review Panel |
Dental |
|||
| statement |
statement |
|||
| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |