(259 days)
The Champions Implants MIMI 1-Piece Precision Implant is intended to support single or multi-unit restorations in both long-term and temporary applications throughout the maxillary and mandibular arches. The MIMI 1-Piece Precision Implant is indicated for immediate loading when there is good primary stability and an appropriate occlusal load. The MIM1 1-Piece Precision Implants have diameters from 4,0 to 4,5mm and are available in length of 10 to 16mm.
The MIM® 1-Piece Precision Implant is a one piece endosseous dental implant. The thread lengths are 10mm to 16mm. The diameters are 4,0mm and 4,5mm.
This document does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.
The provided text is a 510(k) summary for the "Champions Implants MIMI® 1-Piece Precision Implant," which is a dental implant system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than on performance metrics typically associated with AI/ML devices.
Therefore, I cannot extract the requested information regarding acceptance criteria or a study proving device performance because it is not present in the provided text.
§ 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.