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 |