# K211871: FAICO Dental Implant System and CAD/CAM Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Faico Medical, LLC
- Decided: Nov 18, 2021 after 154 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Faico Dental Implant System is indicated for immediate loading when a good primary implant stability is achieved and with appropriate occlusal loading for use in surgical (single-stage or two-stage procedures) and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic device such as artificial teeth and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications. FAICO CAD/CAM Abutments are dental abutments placed onto a dental implant to provide support for dental prosthetic restorations. The abutments include: 1) Titanium abutment blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques; and 2) Titanium bases with a pre-machined implant connection upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutment. The abutments include an abutment screw for fixation to the underlying implant. The abutments may be used for single-unit (single-tooth) or multiple-unit (bridges and bars) restorations and are compatible for use with FAICO Dental Implants with internal hex- connection mating platform and conical connection platform diameters. All digitally designed abutments and/or copings for use with FAICO CAD/CAM Abutments are intended to be sent to a FAICO-validated milling center for manufacture. FAICO abutments designed using CAD/CAM techniques must fulfill the FAICO allowable range of design parameters.

Source page: https://510kreport.com/device/K211871
Methodology: https://510kreport.com/methodology