The following data is part of a premarket notification filed by Leone Spa with the FDA for Leone Implant System.
| Device ID | K050586 |
| 510k Number | K050586 |
| Device Name: | LEONE IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | LEONE SPA 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Greg Holland |
| Correspondent | Greg Holland LEONE SPA 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-07 |
| Decision Date | 2006-02-27 |
| Summary: | summary |