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 |