(192 days)
The SQ EB System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Smaller (e 3.5, o 4.0, o 5.0) implants are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger (e 6.0, e 7.0, e 8.0) implants are dedicated for the molar region and not indicated for immediate loading.
The SQ EB System is a dental implant system made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. The system is similar to other commercially available products based on the intended use, the technology used, the material composition employed and performance characteristics. EB System is made from pure titanium and the surface treatment is done with R.B.M.
This document is a 510(k) summary for a dental implant system (SQ EB System) seeking FDA clearance. It does not contain information about acceptance criteria or a study that proves the device meets those criteria, as it is a premarket notification for substantial equivalence, not a performance study report for an AI/CADe device.
Therefore, I cannot provide the requested information based on the provided text. The document focuses on establishing substantial equivalence to predicate devices based on design, materials, indications, and intended use, rather than presenting a detailed performance study with acceptance criteria for a new AI/CADe device.
The information sought, such as acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies, are typically found in documents related to the evaluation of AI/CADe products, which rely on defined metrics and clinical performance data. This document describes a traditional medical device, a dental implant, and not an AI-powered one.
§ 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.