The following data is part of a premarket notification filed by Itena Clinical with the FDA for Dento Temp.
| Device ID | K122549 |
| 510k Number | K122549 |
| Device Name: | DENTO TEMP |
| Classification | Cement, Dental |
| Applicant | ITENA CLINICAL 500 BOUL CARTIER WEST Laval, CA H7v 5b7 |
| Contact | Louis-paul Marin |
| Correspondent | Louis-paul Marin ITENA CLINICAL 500 BOUL CARTIER WEST Laval, CA H7v 5b7 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-21 |
| Decision Date | 2013-04-26 |
| Summary: | summary |