The following data is part of a premarket notification filed by Leader Italia S.r.l. with the FDA for Tixos Implant System.
| Device ID | K120792 |
| 510k Number | K120792 |
| Device Name: | TIXOS IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | LEADER ITALIA S.R.L. 611 WEST 5TH ST, THIRD FLOOR Austin, TX 78701 |
| Contact | Stuart R Goldman |
| Correspondent | Stuart R Goldman LEADER ITALIA S.R.L. 611 WEST 5TH ST, THIRD FLOOR Austin, TX 78701 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-15 |
| Decision Date | 2012-09-05 |
| Summary: | summary |