The following data is part of a premarket notification filed by Itena Clinical with the FDA for Provitemp, Dentotemp, Totalcem, Dentocem.
| Device ID | K121804 |
| 510k Number | K121804 |
| Device Name: | PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM |
| 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 | 2012-06-19 |
| Decision Date | 2013-04-19 |
| Summary: | summary |