The following data is part of a premarket notification filed by Sudimplant Sa with the FDA for Tbr Idea Conic/conic.
| Device ID | K050956 |
| 510k Number | K050956 |
| Device Name: | TBR IDEA CONIC/CONIC |
| Classification | Implant, Endosseous, Root-form |
| Applicant | SUDIMPLANT SA 24 IMPASSE RENE COUZINET- PARC DE LA PLAINE Toulouse, FR 31500 |
| Contact | Didier Sailhan |
| Correspondent | Didier Sailhan SUDIMPLANT SA 24 IMPASSE RENE COUZINET- PARC DE LA PLAINE Toulouse, FR 31500 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-15 |
| Decision Date | 2006-02-16 |
| Summary: | summary |