The following data is part of a premarket notification filed by Faico Medical Llc with the FDA for Faico Dental Implant System.
| Device ID | K192015 |
| 510k Number | K192015 |
| Device Name: | Faico Dental Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | FAICO Medical LLC 9689 Parkview Ave Boca Raton, FL 33428 |
| Contact | Hernan Dario Fernandez |
| Correspondent | Raymond Kelly Licensale Inc 3422 Leonard Ln New Smyrna Beach, FL 32168 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-29 |
| Decision Date | 2020-04-03 |