(177 days)
ITI One Part octa implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients.
ITI one-part octa implants are for use in edentulous jaws in conjunction with barborne superstructure on 4 implants. If ITI one-part implants are splinted with a bar, they can be loaded immediately.
ITI one-part implants can also be used for indications requiring endosseous implants for functional rehabilitation in regions where an ITI two part implant and an Octa abutment would normally be used.
The All-in-O re implants are screw type dental implants made from CP titanium. Grade 4. They are available in various insertion lengths. The implants have the same rough surface as cleared ITI endosseous implants. The transmucosal part has a smooth machined surface to allow for the attachment of epithelial tissue.
The provided document is a 510(k) summary for a dental implant system (ITI Dental Implant System®) seeking substantial equivalence to existing devices. It does not contain information on the acceptance criteria, study details, or performance of an AI/ML powered device. The document is primarily focused on the device description, intended use, and a comparison to predicate devices, which are all traditional medical devices and not AI-based.
Therefore, I cannot extract the requested information from the given text as it pertains to AI/ML device 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.