| Device Classification Name |
cement, dental |
|||
|---|---|---|---|---|
| 510(k) Number | K022150 | |||
| Device Name | TRIONOMER | |||
| Original Applicant |
|
|||
| Original Contact | annmarie tenero | |||
| Regulation Number | 872.3275 | |||
| Classification Product Code |
|
|||
| Date Received | 07/02/2002 | |||
| Decision Date | 08/21/2002 | |||
| Decision |
substantially equivalent (SESE) |
|||
| Regulation Medical Specialty |
Dental |
|||
| 510k Review Panel |
Dental |
|||
| summary |
summary |
|||
| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |