The following data is part of a premarket notification filed by Sudimplant Sa with the FDA for T.b.r. Zirconnect.
| Device ID | K070935 |
| 510k Number | K070935 |
| Device Name: | T.B.R. ZIRCONNECT |
| 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 | 2007-04-03 |
| Decision Date | 2007-11-09 |
| Summary: | summary |