The following data is part of a premarket notification filed by Itena Clinical with the FDA for Obturys.
| Device ID | K170207 |
| 510k Number | K170207 |
| Device Name: | Obturys |
| Classification | Resin, Root Canal Filling |
| 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 H7l5b7 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-24 |
| Decision Date | 2017-07-31 |