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Faico Dental Implant System is indicated for immediate loading when good primary 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 abutments include an abutment screw for fixation to the underlying implant. The abutments may be used for single-unit (singletooth) 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.

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I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for the Faico Dental Implant System and CAD/CAM Abutments, outlining its regulatory clearance, indications for use, and general regulatory requirements. It does not include details on performance studies, test sets, ground truth establishment, or expert involvement for AI/ML device validation.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided input.

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FAICO CMF System is implantable bone plates and bone screws for maxillofacial and mandible surgery procedures including:

1. Fractures
2. Osteotomies
3. Reconstructive procedures
4. Revision procedures where other treatments or devices have failed.

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The provided text is a 510(k) clearance letter from the FDA for a medical device called the "FAICO CMF System." This document primarily focuses on regulatory approval based on substantial equivalence to existing devices and outlines the indications for use.

It does not contain information about acceptance criteria, specific device performance data, study designs (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance), or training set details for AI/algorithm-based devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is a regulatory approval, not a scientific study report.

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Immediate loading when good primary 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.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the Faico Dental Implant System. It does not contain information about acceptance criteria, device performance, study details, human reader studies, or ground truth establishment relevant to AI/ML device evaluations.

Therefore, I cannot extract the requested information from this document. The document primarily focuses on the regulatory clearance of a physical medical device (dental implants) and does not describe any AI/ML components or performance studies for such components.

Ask a specific question about this device