The following data is part of a premarket notification filed by Leone Spa with the FDA for Leone Monoimplant For O-ring Overdenture.
| Device ID | K070483 |
| 510k Number | K070483 |
| Device Name: | LEONE MONOIMPLANT FOR O-RING OVERDENTURE |
| Classification | Implant, Endosseous, Root-form |
| Applicant | LEONE SPA 50, VIA P. A QUARACCHI Sesto, Florentino, IT I-50019 |
| Contact | Elia Ladani |
| Correspondent | Elia Ladani LEONE SPA 50, VIA P. A QUARACCHI Sesto, Florentino, IT I-50019 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-20 |
| Decision Date | 2007-04-19 |
| Summary: | summary |