(267 days)
GS 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 internediate abutment support for fixed bridgework. GS System is for one stage surgical procedures. It is not intended for immediate load.
The GS 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 GS System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The differences between them are shape. The surface treatment of the SS System is R.B.M. (Resorbable Blasting Media) and that of GS system is R.B.M. or CellNest.
The GS System is substantially equivalent in design, function and intended use to the SS System of Osstem Implant Co., Ltd.
This document does not contain the information required to populate the fields of the table provided. The 510(k) submission describes a dental implant system (GS System) and argues for its substantial equivalence to a predicate device (SS System) based on similar materials, indications for use, design, and technological characteristics.
The document states that "Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations," and that the device "has been subjected to safety, performance, and product validations prior to release." However, it does not provide specific acceptance criteria, performance metrics, or details of any studies demonstrating that the device meets those criteria.
Therefore, I cannot extract the requested information about acceptance criteria, reported device performance, sample sizes, data provenance, ground truth establishment, MRMC studies, or standalone algorithm performance.
§ 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.