The following data is part of a premarket notification filed by Leader Italia S.r.l. with the FDA for Implus Implant System.
| Device ID | K062931 |
| 510k Number | K062931 |
| Device Name: | IMPLUS IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | LEADER ITALIA S.R.L. 1349 LEXINGTON AVE. New York, NY 10128 |
| Contact | Henry J Vogelstein |
| Correspondent | Henry J Vogelstein LEADER ITALIA S.R.L. 1349 LEXINGTON AVE. New York, NY 10128 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-28 |
| Decision Date | 2007-11-28 |
| Summary: | summary |