The following data is part of a premarket notification filed by Ziacom Medical Sl with the FDA for Ziacom Dental Implant Systems.
| Device ID | K182908 |
| 510k Number | K182908 |
| Device Name: | Ziacom Dental Implant Systems |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Ziacom Medical SL Calle Buhos, 2 Pinto, ES 28320 |
| Contact | Olegario Cuevas |
| Correspondent | Alvaro Idiago Ziacom Medical SLU Calle Buhos, 2 Pinto, ES 28320 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-17 |
| Decision Date | 2019-07-18 |