The following data is part of a premarket notification filed by Biosaf In S.r.l. with the FDA for Winsix Implant System.
| Device ID | K133733 |
| 510k Number | K133733 |
| Device Name: | WINSIX Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BIOSAF IN S.R.L. VIA A. ALTOBELLI BONETTI, 3/A Imola, Bo, IT 40026 |
| Contact | Maurizio Pantaleoni |
| Correspondent | Maurizio Pantaleoni BIOSAF IN S.R.L. VIA A. ALTOBELLI BONETTI, 3/A Imola, Bo, IT 40026 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-06 |
| Decision Date | 2015-01-28 |
| Summary: | summary |