The following data is part of a premarket notification filed by Avinent Implant System, S.l. with the FDA for Avinent Dental Implant System.
| Device ID | K121873 |
| 510k Number | K121873 |
| Device Name: | AVINENT DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | AVINENT IMPLANT SYSTEM, S.L. POL. IND SANTA ANNA APARTAT 20 Santpedor, ES 08251 |
| Contact | Anna Cortina |
| Correspondent | Anna Cortina AVINENT IMPLANT SYSTEM, S.L. POL. IND SANTA ANNA APARTAT 20 Santpedor, ES 08251 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-27 |
| Decision Date | 2013-12-11 |
| Summary: | summary |