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The FRIALOC Dental Implant System is indicated for single-stage implant placement, with a minimum healing phase of three months in good quality bone and four months in spongy bone, for freestanding maxillary and mandibular bridges and bar-retained overdenture restorations. The bridge must be supported by a minimum of two FRIALOC transgingival threaded implants.

In the edentulous maxilla, a minimum of four FRIALOC transgingival threaded implants are placed in a trapezoidal distribution and rigidly splinted together.

In the edentulous mandible, a minimum of four FRIALOC transgingival threaded implants are placed between the mental foramina and rigidly splinted together. In this case, bar-prosthetic loading is possible immediately after implant placement.

The FRIALOC Dental Implant System consists of transgingival threaded dental implants in 3.5 and 4.0mm diameters with 10 - 18mm lengths. The implants are coated with the FRIOS Deep Profile Surface. The FRIALOC Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for immediate prosthetic loading using bar-retained overdentures in the edentulous mandible. The FRIALOC Dental Implant System can be used for two stage procedures for freestanding posterior maxillary and mandibular bridges.

I am sorry, but based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them. This document is a 510(k) premarket notification for the FRIALOC® Dental Implant System and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria.

Here's why the requested information is not available in the provided text:

• No detailed performance study: The document repeatedly states "substantial equivalence" to other marketed devices based on design, materials, coatings, prosthetic options, mechanical strength, and intended use. It does not describe a new study designed to test specific performance metrics against pre-defined acceptance criteria.
• No acceptance criteria: Since no performance study is described, there are no acceptance criteria mentioned for device performance.
• No sample sizes, data provenance, ground truth, or expert details: These details are relevant for a new performance study. As this document relies on substantial equivalence and comparisons to existing devices, these elements are absent.
• No MRMC or standalone study information: The document does not discuss human reader performance, AI assistance, or standalone algorithm performance, as these concepts are not applicable to the type of dental implant device being described in this 510(k).

The core of this 510(k) submission is to show that the FRIALOC® Dental Implant System is "substantially equivalent" to existing, legally marketed devices. This means that the FDA determined it is as safe and effective as those predicate devices without requiring a full Premarket Approval (PMA) application, which would typically involve more extensive clinical data and detailed performance studies against specific endpoints.

Therefore, the table and other requested information related to a performance study and its acceptance criteria cannot be extracted from this document.

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