The following data is part of a premarket notification filed by Faico Medical Llc with the FDA for Faico Dental Implant System And Cad/cam Abutments.
| Device ID | K211871 |
| 510k Number | K211871 |
| Device Name: | FAICO Dental Implant System And CAD/CAM Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Faico Medical LLC 2424 North Federal Highway, Suite 103 Boca Raton, FL 33428 |
| Contact | Hernan Dario Fernandez |
| Correspondent | Raymond Kelly Arazy Group 3422 Leonardo Lane New Smyrna Beach, FL 32168 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-17 |
| Decision Date | 2021-11-18 |