The following data is part of a premarket notification filed by Implants Microdent System S.l with the FDA for Microdent Ektos Implant System.
| Device ID | K153650 |
| 510k Number | K153650 |
| Device Name: | Microdent Ektos Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | IMPLANTS MICRODENT SYSTEM S.L C/ CARLES BUIGAS, I-CAN MAGRE Santa Eulalia De Roncana, ES 08187 |
| Contact | Jordi Clapes Donadeu |
| Correspondent | Jordi Clapes Donadeu IMPLANTS MICRODENT SYSTEM S.L C/ CARLES BUIGAS, I-CAN MAGRE Santa Eulalia De Roncana, ES 08187 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-21 |
| Decision Date | 2016-05-20 |
| Summary: | summary |