(209 days)
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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.