The following data is part of a premarket notification filed by Itena Clinical with the FDA for Totalc-ram.
| Device ID | K162960 |
| 510k Number | K162960 |
| Device Name: | TotalC-Ram |
| Classification | Cement, Dental |
| Applicant | ITENA CLINICAL 83 AVENUE FOCH Paris, FR 75116 |
| Contact | Charles Peyre |
| Correspondent | Me Louis-paul Marin LOK North America Inc. 2025 Michelin Laval, CA H7l 5b7 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-24 |
| Decision Date | 2017-03-14 |
| Summary: | summary |